Executive Summary

The European Union's Medical Device Regulation (MDR) has fundamentally transformed the landscape of medical device compliance. What was once a manageable documentation process has evolved into a complex, resource-intensive endeavor that challenges even the most established manufacturers.

This whitepaper examines the critical challenges manufacturers face when generating MDR-compliant technical files and explores how digital transformation can provide a path forward. With notified body capacity severely constrained and the infamous "three-strike" review system unforgiving of incomplete submissions, the cost of inadequate preparation has never been higher.

Key findings include:

• Technical file preparation costs have increased 40-60% under MDR compared to the previous MDD framework

• Average notified body review cycles extend 6-18 months, with pre-check failures adding 8-12 weeks

• Up to 70% of initial submissions receive major nonconformities in the first review round

• The three-strike system means manufacturers have limited opportunities to correct deficiencies before facing costly resubmission

For medical device manufacturers navigating this new regulatory reality, the question is no longer whether to invest in technical file excellence, but how to achieve it efficiently and sustainably.

Introduction: The MDR Compliance Imperative

The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) represents the most significant regulatory shift in European medical device history. With full implementation now mandatory, manufacturers face unprecedented documentation requirements that challenge traditional approaches to technical file creation.

The Scale of Change

The MDR introduced sweeping changes that fundamentally altered technical file requirements:

• Enhanced clinical evidence standards requiring comprehensive clinical evaluation reports with stricter equivalence criteria

• Expanded post-market surveillance documentation and lifecycle management obligations

• Increased traceability demands across all technical file components

• Stricter notified body oversight with reduced capacity and more rigorous review processes

Why Traditional Approaches Fall Short

Manual, document-based approaches to technical file creation that served manufacturers adequately under the MDD are now:

• Too slow to keep pace with iterative review cycles

• Too error-prone to meet stringent traceability requirements

• Too inflexible to accommodate continuous updates and change controls

• Too fragmented to maintain consistency across interconnected documentation

The result? Manufacturers find themselves trapped in a cycle of revisions, delays, and mounting costs—with their market access hanging in the balance.

The Core Challenges

1. High Costs and Resource Demands

MDR compliance has dramatically increased the financial burden on manufacturers of all sizes.

Resource-Intensive Documentation

Creating a compliant technical file now requires:

• Extensive testing protocols and validation studies

• Comprehensive clinical evaluation with literature reviews

• Detailed risk management documentation aligned with ISO 14971

• Post-market surveillance plans and periodic safety update reports

• Complete design and development documentation with full traceability

The average cost to prepare a technical file has increased 40-60% compared to MDD requirements, with Class III devices often exceeding €200,000 in preparation costs alone.

Specialist Expertise Requirements

Few manufacturers possess all necessary expertise in-house:

• Regulatory affairs professionals familiar with MDR nuances

• Clinical evaluators with medical and scientific credentials

• Quality management specialists versed in risk management

• Technical writers capable of maintaining document consistency

For small and medium enterprises (SMEs), hiring external consultants for these roles can consume 30-50% of the total compliance budget.

Infrastructure and Systems Investment

Maintaining compliant documentation systems requires:

• Electronic Quality Management Systems (eQMS) with robust version control

• Document management platforms with audit trail capabilities

• Secure collaboration tools for multi-team coordination

• Backup and archiving systems meeting regulatory retention requirements

2. Delays and Bottlenecks

Time-to-market has become increasingly unpredictable under MDR.

Iterative Review Cycles

Technical file creation involves constant iteration between:

• Design and development teams

• Quality assurance and risk management

• Regulatory affairs and clinical evaluation

• Manufacturing and post-market surveillance

Each revision cycle can add 2-6 weeks to the timeline, with lack of clear communication and version control compounding delays.

Data Dependencies

File completion often stalls while waiting for:

• Laboratory test reports and validation studies (4-12 weeks)

• Clinical data from literature reviews or studies (8-24 weeks)

• Supplier declarations of conformity (2-8 weeks)

• Biocompatibility and sterilization validation (6-16 weeks)

Clinical Evaluation Complexity

The enhanced clinical evaluation requirements present unique challenges:

• Extensive literature searches across multiple databases

• Detailed appraisal of clinical data quality and relevance

• Rigorous equivalence demonstrations under stricter MDR criteria

• Integration with risk management and post-market data

• Interpretation of "sufficient clinical evidence" standards

This process requires specialized clinical expertise and access to comprehensive medical literature databases, often extending timelines by 3-6 months.

Notified Body Capacity Constraints

With fewer notified bodies designated under MDR:

• Review queue times extend 6-18 months from submission

• Pre-check feedback can take 4-8 weeks

• Each review round adds 6-12 weeks to the timeline

• Communication delays slow clarification of requirements

3. Ambiguity and Regulatory Uncertainty

Despite detailed regulations, significant interpretation challenges remain.

Vague Requirements

MDR and IVDR often use subjective terminology:

• What constitutes "sufficient" clinical evidence?

• When is equivalence "adequately demonstrated"?

• What level of detail satisfies "state of the art" requirements?

Different regulatory experts may interpret these requirements differently, creating internal disagreements and delaying decisions.

Inconsistent Notified Body Feedback

Manufacturers report significant variability:

• Different notified bodies emphasize different technical file aspects

• Individual auditors within the same body may apply standards differently

• Interpretation of equivalence criteria varies substantially

• Expectations for clinical evaluation depth are inconsistent

Evolving Guidance

The regulatory landscape remains in flux:

• New MDCG guidance documents published regularly

• Harmonized standards updated continuously

• Notified body best practices evolving

• Regulatory expectations shifting based on emerging issues

Keeping documentation aligned with the latest guidance requires constant vigilance and frequent updates.

4. Complexity and Volume of Work

Modern technical files represent an interconnected web of documentation.

Interlinked Documentation Requirements

A complete technical file integrates:

• Design and development files with risk management

• Clinical evaluation reports with post-market surveillance

• Labeling and instructions for use with risk controls

• Manufacturing processes with quality management

• Supplier documentation with device specifications

Changes to any component potentially ripple through the entire file, requiring careful impact assessment and multiple document updates.

Traceability Demands

MDR requires clear, auditable links between:

• User needs and design inputs

• Design inputs and design outputs

• Design outputs and verification activities

• Verification results and validation studies

• Risk controls and labeling warnings

• Post-market data and clinical evaluation updates

Maintaining this traceability matrix manually across hundreds of documents is extraordinarily challenging.

Lifecycle Maintenance

Technical files are living documents requiring updates for:

• Product modifications and design changes

• New clinical data and literature

• Supplier changes and component updates

• Regulatory changes and new guidance

• Post-market surveillance findings

• Periodic safety update reports

Each update must maintain complete documentation consistency and traceability.

5. Lack of Internal Expertise

The regulatory expertise gap has widened significantly under MDR.

Regulatory Specialist Shortage

The market demand for experienced regulatory affairs professionals far exceeds supply:

• Competition for qualified staff drives salary increases

• Training new staff to MDR proficiency takes 2-3 years

• Staff turnover creates knowledge continuity risks

• Small manufacturers struggle to attract top talent

Knowledge Silos

Technical file creation requires cross-functional collaboration, but:

• Engineers may not understand regulatory documentation needs

• Clinicians may not appreciate quality management requirements

• Quality teams may lack clinical evaluation expertise

• Documentation specialists may not grasp technical complexities

These silos lead to incomplete submissions, excessive revision cycles, and notified body nonconformities.

Training Burden

Maintaining current regulatory knowledge requires:

• Regular training on MDR requirements and updates

• Attendance at regulatory conferences and workshops

• Subscription to regulatory intelligence services

• Internal knowledge sharing and documentation

For resource-constrained manufacturers, keeping teams current diverts attention from core compliance activities.

6. Reliance on External Contractors

Many manufacturers outsource specialized activities, introducing new challenges.

Fragmented Processes

Outsourcing clinical evaluation, testing, or documentation creates:

• Coordination challenges across multiple contractors

• Version control issues with externally prepared documents

• Communication delays in clarifying requirements

• Integration difficulties bringing external work into the technical file

Variable Quality

External consultants and contractors deliver inconsistent results:

• Work may not align with notified body expectations

• Documentation format and style may not match internal standards

• Depth of analysis may fall short of requirements

• Quality may not justify premium pricing

Dependency Risks

Relying on external resources creates vulnerabilities:

• Contractor delays jeopardize submission timelines

• Contractor errors require costly rework

• Loss of key contractor relationships disrupts continuity

• Limited contractor availability during peak periods

Resource Availability

The finite pool of qualified regulatory consultants means:

• Increased competition for expert time

• Rising consultant fees

• Longer lead times to secure support

• Risk of unavailability during critical submission periods

7. Notified Body and Audit Challenges

The notified body landscape has transformed dramatically under MDR.

Limited Availability

The number of MDR-designated notified bodies has decreased significantly:

• Longer queue times for initial reviews

• Delayed responses to queries and clarifications

• Limited appointment slots for audit activities

• Increased pressure on manufacturers to submit perfect files

Inconsistent Interpretations

Variability in notified body approaches creates uncertainty:

• Different emphasis on specific technical file elements

• Varying expectations for clinical evaluation depth

• Inconsistent application of equivalence criteria

• Different tolerances for minor nonconformities

Audit Readiness

Maintaining files in audit-ready condition is challenging:

• Volume of required documentation is substantial

• Frequent change controls require updates

• Cross-references must remain current

• Document version control must be impeccable

Costly Nonconformities

Even minor findings can have major consequences:

• Each nonconformity requires formal response and evidence

• Accumulated minor findings can trigger major NC classification

• Multiple review rounds consume time and budget

• Approaching the third strike risks application rejection

Understanding the Notified Body Review Process

Success with notified bodies requires understanding their structured review approach.

Pre-Checks: The Preliminary Completeness Review

Before formal technical assessment begins, notified bodies perform administrative pre-checks.

Purpose

Pre-checks ensure submissions are formally complete and properly organized before consuming valuable technical reviewer time.

What Notified Bodies Check

• All required MDR Annex II and III sections present

• Key documents included with proper version control

• Cross-references traceable and consistent

• Structure follows notified body submission template

• Declarations, certificates, and signatures provided

• Document formatting and organization adequate

Outcomes

• Accepted: File proceeds to technical assessment queue

• Incomplete: File returned for correction before review begins

Pre-check failures don't count as "strikes" but add 8-12 weeks to the timeline while manufacturers correct deficiencies.

Common Pre-Check Failure Reasons

• Missing Clinical Evaluation Report or incomplete clinical data

• Outdated or unsigned Declaration of Conformity

• Non-aligned references (e.g., labeling version mismatches device version)

• Inadequate document formatting or missing table of contents

• Incomplete risk management file or missing risk-benefit analysis

• Missing supplier declarations or certificates of conformity

The Three-Strike System

Once formal review begins, most notified bodies operate under a structured three-round policy.

How It Works

Round 1: Initial Review

• Notified body conducts comprehensive technical assessment

• Issues list of nonconformities (NCs), categorized as major or minor

• Manufacturer responds with corrections, justifications, or additional data

• Timeline: 8-12 weeks for review, 4-8 weeks for manufacturer response

Round 2: Second Review

• Notified body assesses manufacturer responses

• Issues second NC list if issues remain open or new concerns emerge

• Manufacturer provides second corrective response

• Timeline: 6-10 weeks for review, 4-6 weeks for manufacturer response

Round 3: Final Review

• Last opportunity to resolve outstanding issues

• If major deficiencies remain, application typically rejected

• Manufacturer must reapply from scratch with new fees

• Timeline: 6-10 weeks for review

Why the Three-Strike Rule Exists

• Prevents endless review loops that waste notified body resources

• Incentivizes manufacturers to submit high-quality, complete files initially

• Maintains audit traceability and regulatory fairness

• Ensures efficient use of limited notified body capacity

Typical Triggers for Strikes

• Inadequate risk management alignment with ISO 14971

• Insufficient clinical or performance evaluation evidence

• Poor linkage between design controls, verification, and labeling

• Incomplete justifications for equivalence or legacy data use

• Weak post-market surveillance plans

• Inconsistent documentation across technical file sections

Implications for Manufacturers

• Preparation is critical: Files passing pre-check cleanly and minimizing Round 1 NCs move faster and cost less

• Each strike costs time and money: Review cycles extend timelines by 4-12 weeks or more

• Limited interaction: Communication is primarily written, making clarification slow

• Rejection means restart: Rejected files require fresh submission, new contract, and return to queue

Best Practices to Avoid Strikes

Conduct Internal Mock Audits

• Perform gap assessments against MDR Annex II requirements

• Engage independent reviewers to identify weaknesses

• Test document traceability and cross-references

• Validate clinical evaluation adequacy

Follow Notified Body Templates Strictly

• Use notified body-specific submission templates

• Complete all template sections thoroughly

• Follow formatting and numbering conventions

• Include all requested annexes and appendices

Engage Expert Review Early

• Have regulatory experts review documentation before submission

• Obtain clinical evaluation peer review

• Validate risk management completeness

• Check compliance with latest harmonized standards

Maintain Rigorous Traceability

• Implement robust document version control

• Ensure consistent cross-references throughout file

• Link all design elements to requirements and verification

• Connect risk controls to labeling and instructions for use

Don't Rely on "Fixing During Review"

• Submit only when file is truly complete and audit-ready

• Assume notified body will not provide coaching or guidance

• Prepare thoroughly rather than depending on feedback to identify gaps

• Remember: each review round costs time, money, and opportunity

The Cost of Non-Compliance

The financial impact of inadequate technical file preparation extends far beyond direct regulatory costs.

Direct Costs

Multiple Review Cycles

• Each additional review round: €15,000-30,000 in notified body fees

• Internal team time for response preparation: €20,000-40,000 per round

• External consultant support for corrections: €10,000-25,000 per round

Application Rejection and Resubmission

• Lost notified body fees from rejected application: €50,000-100,000

• Resubmission fees: €50,000-150,000

• Restart of queue position: 6-18 month delay

Extended Timelines

• Each week of delay: potential lost revenue of €10,000-500,000 depending on device

• Competitor advantage during delay period

• Erosion of first-mover advantage for innovative devices

Indirect Costs

Market Access Delays

• Delayed product launches impact revenue projections

• Sales team idle time waiting for regulatory clearance

• Marketing campaigns postponed or wasted

• Distribution agreements jeopardized

Reputational Impact

• Notified body may view manufacturer as less prepared for future submissions

• Difficulty attracting clinical investigators for studies

• Investor confidence impacted by regulatory setbacks

• Customer concerns about company regulatory capability

Opportunity Costs

• Resources diverted to correcting deficiencies unavailable for innovation

• Management attention consumed by compliance crises

• Strategic initiatives delayed while addressing regulatory issues

• Team morale impacted by repeated setbacks

The True Cost: A Case Example

Consider a mid-sized manufacturer submitting a Class IIb device:

Scenario A: Well-Prepared Submission

• Pre-check passed: 4 weeks

• Round 1 with minor NCs only: 10 weeks

• Round 2 clearance: 8 weeks

• Total timeline: 22 weeks

• Total cost: €120,000

Scenario B: Poorly-Prepared Submission

• Pre-check failed, resubmitted: 12 weeks

• Round 1 with major NCs: 12 weeks

• Round 2 with remaining issues: 10 weeks

• Round 3 with final corrections: 10 weeks

• Total timeline: 44 weeks

• Total cost: €180,000 + 22 weeks lost revenue

The difference: 22 weeks and €60,000+ in direct costs, plus immeasurable indirect impacts.

The Digital Solution: Transforming Technical File Creation

Traditional manual approaches to technical file creation are fundamentally mismatched to MDR requirements. Digital transformation offers a path forward.

The Limitations of Manual Processes

Document-Based Systems

• Version control relies on naming conventions and human discipline

• Cross-references become outdated with each revision

• Finding information requires searching multiple documents

• Collaboration depends on email chains and shared drives

• Change impact assessment is manual and error-prone

Spreadsheet-Based Tracking

• Traceability matrices quickly become unmanageable

• No automation of linkages between requirements and design

• Updates require manual entry in multiple locations

• No validation of completeness or consistency

• Audit trail limited or absent

Result: Fragmented, error-prone processes that cannot keep pace with MDR demands.

The Digital Transformation Advantage

Modern SaaS platforms purpose-built for technical file creation offer transformative capabilities.

Structured Data Management

• Technical file content stored as structured, searchable data

• Automated cross-referencing eliminates inconsistency

• Version control built into the platform

• Complete audit trail of all changes

• Single source of truth for all documentation

Intelligent Automation

• Auto-generation of standard sections and summaries

• Automated traceability matrix creation and maintenance

• Intelligent validation of completeness and consistency

• Workflow automation for review and approval

• Automated document assembly for submission

Collaborative Workflows

• Real-time collaboration across teams and locations

• Role-based access control and permissions

• Built-in review and approval workflows

• Comment and annotation capabilities

• Notification and task management

Template and Standards Integration

• Pre-configured MDR Annex II and III templates

• Integration of harmonized standards requirements

• Notified body-specific submission formats

• Best practice guidance and examples

• Continuous updates as guidance evolves

Clinical Evaluation Support

• Structured literature review and appraisal workflows

• Integration with medical literature databases

• Equivalence demonstration frameworks

• Clinical data management and analysis

• PMCF planning and execution tracking

Lifecycle Management

• Change control workflows with impact assessment

• Post-market surveillance integration

• PSUR generation and submission

• Design change management

• Supplier and component tracking

Measuring the Impact

Organizations implementing digital technical file solutions report:

Time Savings

• 40-60% reduction in documentation preparation time

• 70% faster response to notified body questions

• 50% reduction in time to locate and retrieve information

• 30% faster change control processing

Quality Improvements

• 80% reduction in cross-reference errors

• 90% improvement in document version control

• 60% fewer nonconformities in first review round

• 50% reduction in internal review cycles

Cost Reduction

• 30-40% lower overall technical file preparation costs

• 50% reduction in external consultant requirements

• 40% fewer review cycles with notified bodies

• Dramatic reduction in lost revenue from delays

Risk Mitigation

• Near-elimination of document version control errors

• Improved audit readiness and reduced findings

• Better team knowledge management and continuity

• Enhanced traceability and regulatory defensibility

Key Platform Capabilities to Seek

When evaluating digital technical file solutions, prioritize:

MDR-Specific Design

• Built specifically for MDR/IVDR compliance, not generic document management

• Pre-configured templates aligned with Annex II and III

• Embedded regulatory intelligence and guidance

• Regular updates as regulations evolve

Comprehensive Functionality

• Full technical file lifecycle support from design to post-market

• Integration of all required documentation components

• Automated traceability and cross-referencing

• Submission package generation

Usability and Adoption

• Intuitive interface requiring minimal training

• Role-based views for different team members

• Collaborative features for cross-functional teams

• Mobile access for on-the-go reviews

Integration and Flexibility

• Integration with existing QMS and PLM systems

• Import/export capabilities for external documents

• API access for custom integrations

• Scalability to grow with organization

Security and Compliance

• Enterprise-grade security and access controls

• Complete audit trail of all activities

• Compliance with data privacy regulations

• Regular backups and disaster recovery

Support and Partnership

• Regulatory expertise and consulting support

• Training and onboarding assistance

• Ongoing customer success management

• Active user community and knowledge base

Best Practices for MDR Success

Achieving sustainable MDR compliance requires both the right tools and the right approach.

1. Invest in Preparation, Not Remediation

The most successful manufacturers recognize that quality upfront preparation costs far less than correcting deficiencies during review.

Start Early

• Begin technical file preparation in parallel with product development

• Don't wait until design freeze to start documentation

• Build regulatory requirements into design inputs from the start

Plan Comprehensively

• Map complete technical file structure before detailed documentation begins

• Identify data gaps and dependencies early

• Allocate adequate time for each documentation component

Leverage Expertise

• Engage regulatory and clinical experts at project kickoff

• Don't attempt to learn MDR requirements while documenting

• Consider specialized expertise for complex areas like clinical evaluation

2. Implement Robust Document Control

Version control and traceability are non-negotiable under MDR.

Establish Clear Standards

• Define document numbering and versioning schemes

• Create templates for common document types

• Standardize terminology and abbreviations

Use Proper Tools

• Implement purpose-built technical file management systems

• Don't rely on manual processes for critical control functions

• Ensure complete audit trail of changes

Maintain Rigor

• Review and approve all documents formally before use

• Update cross-references immediately when documents change

• Conduct regular audits of document control compliance

3. Build Cross-Functional Collaboration

Technical files require input from across the organization.

Break Down Silos

• Establish technical file working groups with representatives from all functions

• Create clear roles and responsibilities for documentation

• Facilitate regular communication and coordination

Train Broadly

• Ensure all contributors understand MDR requirements

• Provide role-specific training on documentation needs

• Foster shared understanding of quality and regulatory objectives

Use Collaborative Tools

• Implement platforms enabling real-time collaboration

• Provide visibility across teams into documentation status

• Support remote and distributed team collaboration

4. Conduct Internal Reviews

Don't make the notified body your first reviewer.

Mock Audits

• Perform internal gap assessments against MDR requirements

• Engage independent internal reviewers not involved in file preparation

• Identify and correct deficiencies before submission

Peer Review

• Have regulatory peers review documentation for completeness

• Obtain clinical evaluation peer review by qualified experts

• Validate technical content accuracy through subject matter expert review

Checklist-Based Review

• Use comprehensive checklists based on MDR Annex II

• Follow notified body submission requirement checklists

• Verify all cross-references and traceability links

5. Embrace Continuous Improvement

Regulatory compliance is an ongoing journey, not a destination.

Learn from Experience

• Conduct retrospectives after each submission

• Analyze nonconformities to identify root causes

• Update processes and templates based on lessons learned

Stay Current

• Monitor regulatory developments and guidance updates

• Attend industry conferences and training

• Participate in professional networks and associations

Evolve Capabilities

• Regularly assess regulatory team competencies

• Invest in training and development

• Build internal expertise over time to reduce external dependencies

6. Choose the Right Digital Platform

Technology selection significantly impacts long-term success.

Evaluate Strategically

• Assess solutions against your specific needs and constraints

• Consider total cost of ownership, not just license fees

• Involve end users in evaluation and selection

Pilot Carefully

• Test solutions with real projects before full commitment

• Validate claimed capabilities and usability

• Ensure vendor support meets expectations

Implement Thoughtfully

• Plan implementation with adequate time for training and adoption

• Migrate existing content systematically

• Monitor usage and address adoption barriers

Optimize Continuously

• Leverage vendor updates and new capabilities

• Gather user feedback and refine workflows

• Measure outcomes and demonstrate value

Conclusion: Building Sustainable Compliance

The MDR has fundamentally transformed medical device regulation in Europe. Technical file requirements have expanded dramatically, notified body capacity has contracted severely, and the margin for error has effectively disappeared.

For manufacturers, the stakes have never been higher. Inadequate technical file preparation leads to extended review cycles, mounting costs, and potentially catastrophic submission rejections. Market access depends on getting it right the first time.

Yet amid these challenges lies opportunity. The manufacturers that master MDR compliance position themselves for competitive advantage. Those that invest in proper preparation, leverage digital tools, and build robust regulatory capabilities will move products to market faster, with less cost and risk.

The Path Forward

Success in the MDR era requires three fundamental shifts:

1. From Reactive to Proactive: Stop treating technical files as post-development documentation exercises. Integrate regulatory requirements into product development from the start. Build documentation as you build the device, not after.

2. From Manual to Digital: Abandon document-based, spreadsheet-tracked approaches that cannot scale to MDR complexity. Embrace purpose-built digital platforms that automate traceability, enable collaboration, and ensure consistency.

3. From Isolated to Collaborative: Break down silos between regulatory, quality, clinical, and engineering teams. Foster cross-functional collaboration and shared understanding of compliance objectives. Leverage external expertise strategically while building internal capabilities.

Taking Action

The transition to digital technical file creation represents a significant undertaking, but the return on investment is clear:

• Faster time to market through streamlined documentation processes

• Lower costs through reduced review cycles and external dependencies

• Reduced risk through improved quality and consistency

• Enhanced capability to manage product portfolios across their lifecycle

For manufacturers still relying on manual processes, the question isn't whether to digitize technical file creation, but when. Each submission cycle that passes represents lost opportunity to work more efficiently and effectively.

Next Steps

Organizations ready to transform their technical file processes should:

• Assess current state: Conduct honest evaluation of existing technical file capabilities and challenges

• Define requirements: Articulate what success looks like for your organization

• Explore solutions: Investigate digital platforms purpose-built for MDR technical files

• Pilot and validate: Test solutions with real projects to validate capabilities

• Implement strategically: Roll out with proper training, migration, and change management

The MDR compliance challenge is formidable, but not insurmountable. With the right approach, tools, and commitment, manufacturers can achieve not just compliance, but excellence—positioning themselves for sustained success in the European market.

About Obodux

Obodux is a SaaS platform that digitizes the creation of technical files for medical devices, purpose-built for MDR/IVDR compliance. Our solution helps manufacturers streamline documentation, automate traceability, enable collaboration, and accelerate time to market—all while reducing costs and risk.

Thousands of medical device professionals trust Obodux to manage their most critical regulatory documentation, from design inputs through post-market surveillance.

Ready to transform your technical file process? Start a 4-week free trial of Obodux, or read the short version in The MDR Technical File Challenge: An Executive Brief.

This whitepaper is provided for informational purposes only and does not constitute regulatory or legal advice. Manufacturers should consult with qualified regulatory professionals regarding their specific compliance obligations.