I provide professional Quality Management, Regulatory Affairs and Compliance consulting services for medical device manufacturers, suppliers, start-ups and consulting partners in Switzerland, Germany and the EU.
With 24 years of experience in Quality Management, including 16 years in the medical device industry, I support organizations in building, improving and maintaining audit-ready quality and regulatory processes for medical devices, including active medical devices and software-related products.
My services include:
- ISO 13485 Quality Management System support and process optimization
- EU MDR 2017/745 compliance support
- FDA quality system and documentation support
- Clinical Evaluation Reports, CER, and clinical documentation support
- Post-Market Surveillance, PMS, PMCF and PSUR support
- Complaint Handling, vigilance and trend reporting processes
- Risk Management according to ISO 14971
- Usability Engineering according to IEC 62366
- Electrical safety and performance documentation support according to IEC 60601 series
- Medical device software lifecycle documentation according to IEC 62304
- Cybersecurity documentation and regulatory gap assessments for connected medical devices
- EU AI Act impact assessment in connection with EU MDR 2017/745 for medical device software and AI-supported medical devices
- UDI implementation and labeling compliance
- Labeling and symbols according to ISO 15223
- Packaging validation and sterile barrier system documentation according to ISO 11607
- Biocompatibility documentation and biological evaluation support according to ISO 10993
- Worldwide medical device product registration support
- Supplier qualification, supplier audits and purchasing controls
- CAPA and Nonconformity Management
- Process validation and documentation review
- Technical documentation gap assessments and remediation
- Internal audit preparation and notified body audit support
- SOP development, QMS documentation and quality process improvement
I help clients identify compliance gaps, improve technical and quality documentation, prepare for audits and implement practical solutions that fit their business needs and regulatory obligations.
My working style is structured, precise and results-oriented. I focus on clear deliverables, realistic timelines and documentation that can stand up to internal audits, customer audits, notified body audits and regulatory authority expectations.
I am particularly interested in freelance, project-based and interim consulting opportunities with Swiss and European medical device companies, suppliers and consulting firms.