The team building technical file software for medical device manufacturers
Obodux is the MedTech compliance product from BORIS Software Ltd. We build software that helps small and mid-sized medical device manufacturers prepare, organise and maintain their EU MDR and UKCA technical documentation.
Many manufacturers hold their technical file across Word documents, spreadsheets and shared drives, and rely on expensive consultants to pull it together before a notified body review. Obodux gives them one structured workspace, AI drafting their team controls, and regulatory specialists to review the sections that matter most.
The team behind Obodux
CEO
Damien McKenna
Serial entrepreneur
- CEO of Obodux, BORIS Software, TECL and Absolute Commercial Interiors
- Early innovator in SaaS for construction compliance
- Extensive regional network
CTO
Amila Palahepitiya Gamage
Technology lead
- CTO of a venture-funded US fintech
- Founder of VoiceIQ (exited)
- Leads an AI-native software development agency
Regulatory Expert
Simon Taylor
Chartered mechanical engineer, PhD
- Led Paxman's EU MDR project through to certification
- Former Technical Manager and Risk & Compliance Manager at Paxman (FDA, MDD, MDR, Health Canada)
- Took COVVI's Nexus bionic hand through its regulatory pathways
- Medical device design background, including the Bebionic hand
What we believe
Structure beats scramble
A technical file built around MDR Annex II and III is easier to review, easier to keep current and harder to get wrong.
AI assists, people decide
AI drafts and suggests. Your team reviews, edits and approves every change, and stays responsible for the file.
Expert review when it counts
Software handles the structure and the routine work. Regulatory specialists add judgement where it matters.
Built for smaller manufacturers
Enterprise eQMS tools and day-rate consultants are out of reach for many device makers. Obodux is designed for them.
Part of BORIS Software
BORIS Software Ltd builds compliance software for regulated industries, including workforce management and fire safety compliance. Obodux applies the same approach to medical device technical documentation. Visit BORIS Software.
See Obodux with your own documents
Start with a free gap analysis of your current technical file, or try Obodux free for 4 weeks.
Get a free gap analysisStart 4-week free trialObodux is a documentation tool from BORIS Software Ltd. It does not provide legal or regulatory advice and does not guarantee CE, UKCA or any other approval. AI suggestions are guidance only, and manufacturers remain responsible for their technical documentation.
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