MDR Tech Lead supporting regulated software teams
Define requirements, traceability, QA systems, and lead audits to navigate MDR Class IIb compliance efficiently and confidently.
Services & Tools
QMS Design & Implementation
Establish a robust, audit-ready quality management system with clear SOPs, traceable processes, and pragmatic trade-offs documented for regulatory compliance.
MDR Documentation & Compliance
Maintain MDR Class I/IIa/IIb documentation for traceability, audit readiness, and regulatory clarity.
Regulatory Gap Analysis
Identify compliance gaps and provide actionable steps to achieve MDR readiness efficiently.
Requirements & Traceability
Define requirements linked to tests, risks, and releases for audit-ready, compliant software.
Internal Audits & Readiness
Plan and conduct internal audits to validate processes and prepare for MDR Class I/IIa/IIb assessments.
Cybersecurity & Vulnerability Oversight
Implement risk-informed vulnerability management and cybersecurity practices under MDR constraints.