Medical Device Regulatory & Quality Consulting
Practical, audit-ready templates and regulatory support for global medical device and IVD manufacturers.
What I Offer
Risk Management Templates
ISO 14971–aligned risk management files, hazard analysis, risk-benefit, and post-market risk updates designed to withstand regulatory scrutiny.
CAPA Management Templates
Investigation-driven CAPA templates focused on root cause, effectiveness checks, and inspection-ready documentation.
Gap Assessment Templates
Structured gap assessment frameworks for ISO standards and global medical device regulations.
510(k) Submission Support
Predicate identification, submission structure, and review support aligned with current US FDA expectations.
EU MDR & CDSCO Registration
End-to-end support for EU MDR compliance and CDSCO registration, licensing, and post-market obligations.
EU AI Act Gap Assessment
Structured gap assessments for AI-enabled and SaMD products against EU AI Act requirements, covering risk classification, governance, data management, and lifecycle controls.
Regulations & Standards Covered
Who This Is For
• Medical device & IVD startups building their first QMS
• Manufacturers scaling to EU, US, and global markets
• QA/RA teams looking for ready-to-use, regulator-friendly documentation
Make Compliance Structured, Not Stressful
If regulatory compliance feels complex, it’s usually because the structure is missing. I help you build that structure — clearly, practically, and audit-ready.
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