Anke Maaßen

• 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.

Education:

Biochemist (Diploma)

PhD (Dr. rer. nat.)

Researcher and Lecturer at the Institute of Biochemistry and Institute of Medical Immunology, University Hospital Berlin (Charité)

Experience:

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