Reviews & Remediation
Know where you stand before your regulator does. We independently review your engineering and regulatory evidence to identify gaps, prioritise remediation and strengthen submission readiness.
Organisations we support.
- Teams preparing for submission, audit or notified-body review.
- Acquirers and investors assessing a product's regulatory position before or after a deal.
- Companies that have inherited documentation they didn't produce.
- Organisations responding to findings from an audit, regulator or approved body.
What typically goes wrong.
- No objective view of how far the current evidence actually is from compliant.
- Findings raised late, when remediation is most expensive and most disruptive.
- Remediation lists with no prioritisation, so teams fix the easy things first.
- Documentation that looks complete but does not trace to the software as built.
The work we perform.
Regulatory Compliance & Readiness Review
Our flagship deterministic gap analysis against IEC 62304, ISO 13485, ISO 14971, MHRA and EU MDR expectations.
Software lifecycle & DHF assessment
Assessment of lifecycle processes and Design History File content against the software as built.
QMS & Technical Documentation assessment
Review of quality system and submission documentation for completeness, consistency and traceability.
Inherited & acquired product reviews
Establishing the true regulatory position of software acquired or transferred into your organisation.
Prioritised remediation
A sequenced action plan ordered by regulatory risk, with the effort required made explicit.
Remediation delivery
Where wanted, our engineering and regulatory specialists carry out the remediation with you.
What you might receive.
Scope is agreed per engagement — the outputs below are typical examples.
Findings are produced by people who have built regulated software as well as submitted it. That means remediation advice is technically achievable, not just regulatory in the abstract — and where you want it, the same team can deliver the fix.
Assess. Remediate. Review-Ready.
You receive a private working document — the Veracity Report — that surfaces documentation gaps and gives a prescriptive action plan for remediation. It is used internally by your team before any formal regulatory review takes place.
Assess
Deterministic gap analysis of your software lifecycle, quality system and Technical Documentation against IEC 62304, ISO 13485, ISO 14971, MHRA and EU MDR expectations.
Remediate
A prescriptive, prioritised action plan — what to fix, in what order, and what evidence each action must produce.
Review-Ready
You enter formal review with a defensible, audit-ready position rather than discovering gaps under scrutiny.
What you supply
- Software lifecycle documentation and plans
- Design History File or equivalent records
- Quality system procedures
- Risk management file
- Technical Documentation, where it exists
How Vera supports the analysis
MediLife Vera applies deterministic clause-level analysis across the material you supply, mapping evidence to the applicable requirements of IEC 62304, ISO 13485 and ISO 14971 and surfacing where evidence is absent, partial or inconsistent.
Explore Vera →How our specialists review findings
Every finding is reviewed by our engineering and regulatory specialists before it reaches you. They confirm context, discard false positives, judge regulatory significance and set the remediation sequence — so what you receive is a considered professional assessment, not raw tool output.
Find the gaps first.
A Readiness Review gives you a defensible position before any formal review takes place.