Medical Device Compliance & Certification Readiness

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 before audit or conformity work
• EU MDR/IVDR or US device pathways require clearer file structure and ownership
• Remediation work must be prioritised against real submission or audit timelines

How we work

1. Inventory — what documentation and process artefacts exist
2. Gap analysis — readiness notes against the client’s target framework
3. Structure — documentation organisation and prioritised remediation
4. Coordinate — link to SaMD/software and regulatory writing as needed
5. Hand over — client owns QMS, notified-body and certification relationships

See How we work and MedTech.

Gap categories we typically examine

Scope follows the client’s claimed pathway and the file that pathway actually requires.

• Intended use and claims — consistency across labelling, marketing and technical docs
• Risk management — hazard analysis, residual risk and linkage to design controls
• Design / development evidence — design history and change control completeness
• Software / SaMD files — lifecycle, SOUP, V&V and cybersecurity inputs when software is in scope
• Clinical / performance evidence — structure and ownership of evaluation documentation
• QMS interface — how artefacts sit in the client’s quality system

Documentation structure

• Technical file / design history file organisation proposals suited to the target region
• Traceability expectations between requirements, risk controls and verification evidence
• Prioritised remediation lists with owners and suggested sequencing
• Coordination notes so engineering, clinical and RA contributions stay one story

In scope

• Documentation structuring and gap analysis for readiness
• Coordination with SaMD/software and regulatory writing support
• Process clarifications for the client’s quality system
• Explicit EU- and US-oriented readiness notes when both markets matter

Example deliverables

• Gap and readiness summaries
• Documentation structure proposals
• Prioritised action lists for client remediation
• Inputs to regulatory writing packages for submissions

FAQ

Is this the same as regulatory writing?
Related but distinct. Device readiness focuses on file structure and gaps; regulatory support covers strategy, writing and agency interaction preparation.

Related

Regulatory support · SaMD support · Medical software · MedTech

For role boundaries (regulator, notified body, certification, outcomes), see Trust.