Solutions and services
With her own business since 2000, Anne offers technical guidance on CE marking requirements, regulatory strategies for the commercialization of new products, implementation of management systems to ISO 13485:2012 and training in all these areas. She has worked with companies ranging from start-up university spin out companies to multi-national market leaders.
As a Lead Auditor, Anne carries out gap analysis compliance audits for manufacturers and subcontract regulatory and quality management audits for Notified Bodies.
Medical and Diagnostic Device Regulatory Advice
General guidance and explanation of CE marking requirements in order to place medical and diagnostic devices on the European market.
- Preparation of regulatory strategies for the commercialization of new products
- Preparation of Technical files to meet the requirements of European Directives 93/42/EEC and 98/79/EC
- Assistance with the compliance related aspects of sterility assurance
Quality Management Systems
- Implementation of documented quality management systems to ISO 9001 and ISO 13485
- Advice on requirements for the US FDA Quality System Requirements (QSRs)
For Manufacturers and Own Brand Labellers:
- Compliance audits 1of technical files and regulatory procedures and systems
- Gap analysis audits
- Internal audits to fulfill the ISO 9001 / ISO 13485 requirement for internal quality audits
- Supplier audits