Compliancy for Medtech Companies
25+ years of experience in Quality Management and Regulatory Affairs, Medical Devices and Medical Products
Special knowledge and support
- Quality Management according ISO 13485:2016 Medical Devices
- Medical Device Directive (MDD 93/42/EC)
- Medical Device Regulation (MDR 2017/745/EC)
- Technical Approvals according IEC 60601-1 and -2 -4 -6 and others
- Conformity Assessments according MDR requirements
- Post Market Surveillance and Vigilance System Support
- US FDA Regulations; 21CFR Part 820, 801, 803, 807, 822
- Technical File Support and Remediation (STED) or MDR Guidance
- Complaints Management, NCR, CAPA, Investigations
- Audits: Internal, Supply Chain, Distributors, Affiliates
- Quality Agreements assessment for vendors and economic operators
- Life Cycle Management according to the Regulatory Standards
- Regulatory Affairs, FDA 510(k), CFDA, Brazil, Japan, Canada, Australia
- MDSAP: Medical Devices Single Audit Program, Assessments
- Experience in all classification requirements Ix IIa, IIb, III
Project Lead
- Quality Management, managed remediation project of quality management systems to
achieve ISO 13485:2016
- Various compliance activities FDA 21 CFR 820.XXX
- Remediation of Technical Documentation DHF, DMF, DHR
- Process Validation for full automated systems and production controls
- Supplier Assessments and Vendor Qualifications
