Medical Device Compliance & Certification Readiness
Readiness support for device documentation and conformity preparation. We do not issue certificates and we are not a notified body.
When this is needed
- Technical documentation has gaps before audit or conformity work
- Software and device files need a consistent story
- Teams need structured gap analysis without implying we “certify”
Methodology
- Inventory — what documentation and process artefacts exist
- Gap analysis — readiness notes against the client’s target framework
- Structure — documentation organisation and prioritised remediation
- Coordinate — link to SaMD/software and regulatory writing as needed
- Hand over — client owns QMS, notified-body and certification relationships
See How we work and MedTech.
In scope
- Documentation structuring and gap analysis for readiness
- Coordination with SaMD/software and regulatory writing support
- Process clarifications for client-owned quality systems
Example deliverables
- Gap and readiness summaries
- Documentation structure proposals
- Prioritised action lists for client remediation
Out of scope
- Issuing CE certificates or acting as a notified body
- Guaranteeing certification timelines or outcomes
- Implying we “certify” devices
Related
Regulatory support · SaMD support · Medical software · MedTech
Ready to discuss a programme?
Tell us about your organisation and the type of support you need. Do not send PHI or confidential regulatory packs through the public form.