Engagement options
Compliance Reality Check (Diagnostic)
For: Companies preparing for audit, funding or scale.
Outcome: Clear report identifying structural weaknesses in control, traceability and risk integration.
Timeframe: 1-2 weeks.
Deliverables: Executive summary and prioritised action roadmap.
Audit/Submission Readiness
For: MedTech and SaMD teams preparing for:
EU MDR audit
UKCA assessment
FDA inspection or submission
Outcome: A technically coherent, defensible regulatory system that holds up to scrutiny, not just document review.
Timeframe: 4-8 weeks depending on scope.
Deliverables:
Structured gap analysis
Prioritised remediation plan
Hands on implementation support
Risk management review suitable for upper management
Ongoing Advisory (Fractional QA/RA)
For: Scaling MedTech and SaMD companies that require senior regulatory oversight without full time executive headcount.
Outcome: Regulatory systems that evolve in step with product development, funding milestones and market expansion.
Scope may include:
Acting as Fractional Head of QA/RA
PRRC oversight (where applicable)
Strategic regulatory planning (EU, UK, FDA etc)
Regulatory input into product roadmap
Design and change control governance
Risk management leadership
Audit and inspection preparation
Board level regulatory reporting
Due diligence support for investors or acquirers
Engagement Model:
Retained advisory (monthly)
Defined day allocation per month
Leadership participation in key governance meetings
Due Diligence & Investment Support
For: Companies preparing for funding rounds, acquisition, or strategic partnership.
Outcome: A regulatory position that withstands investor and technical diligence scrutiny.
Includes:
Regulatory maturity assessment
Technical documentation coherence review
Risk and PMS integration analysis
Investor facing regulatory summaries
Risk remediation strategy