Compliance for MedTech Companies

25+ years of experience in Quality Management and Regulatory Affairs, Medical Devices and Medical Products

- Quality Management, managed remediation project of quality management systems to

   achieve ISO 13485:2016, MDSAP and MDR Requirements

- 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

- Rework and update of Medical Device Files according MDR and FDA requirements

Special knowledge and skills

- Quality Management according ISO 13485:2016 Medical Devices

- 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 requirements

- Complaints Management, NCR, CAPA, and Investigations

- Audits: Internal, Supply Chain, Distributors and Affiliates

- Quality Agreements assessments for vendors, and economic operators

- Product 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 and Certification Support

- Experience in all classifications (Is, Im,  IIa, IIb, III)

- Assessments and Support of Economic Operators according to the MDR Requirements