In Vitro Diagnostics – IVDR, Quality Management and Assurance, CMC
Dr. Maaßen Consulting
Services offered worldwide
- Provide RA Services: Regulation (EU) 2017/746 (IVDR)
- Conduct IVDR training
- Consulting in Quality Management (ISO 13485, FDA21CFR Part 820, GMP)
- Perform Internal and Vendor/Supplier Audits
- Moderation (Quality Circles, Risk Management Teams, Transfer Teams)
Dr. Anke Maassen has a broad research and industry background (In total about 30 years in academic research, IVD industries and consulting).
She has over 20 years of experience in 4 IVD companies as Director of R&D and Production. Her main area of responsibility included implementing of quality management systems and ensuring full compliance with all rules, regulations, legal and other requirements in production and R&D.
PhD (Dr. rer. nat.)
Researcher and Lecturer at the Institute of Biochemistry and Institute of Medical Immunology, University Hospital Berlin (Charité)
Consulting and management experience in IVD industries.
Compliance to new regulation (EU) 2017/746 (IVDR) and directive 98/79/EG (IVDD).
Development, Transfer and production of immuno assays including PoC, quality control and assurance, regulatory compliance.
Trainer for IVDR (e.g. TÜV Rheinland Akademie: Technical Documentation, Person responsible for regulatory compliance (PRRC), Post Market Surveillance & Vigilance)
Areas of Expertise:
Regulatory Affairs and Compliance, Chemistry, Manufacturing and Control