- Regulatory Compliance: I ensure compliance with ISO 13485, MDR (CE), FDA 21 CFR Part 820, and other standards. This involves updating procedures, documentation, and processes to meet regulatory requirements.
- Quality Management System (QMS) Implementation: I help design, implement, and maintain a robust QMS tailored to your needs. This includes procedures for document control, risk management, CAPA, supplier management,
and internal audits.
- Risk Management: I lead the risk management process, including hazard analysis, risk assessment, and mitigation strategies integrated into product development.
- Internal Audits and Training: I conduct audits, identify areas for improvement, and provide staff training on quality and regulatory requirements.
- Clean Room Procedures and Validation: I provide guidance on clean room procedures and validate processes for product quality and safety.
- Product Development Support: I assist with regulatory requirements during product development, including design controls, verification and validation testing, and documentation for submissions.
- MDSAP Implementation: I help prepare for MDSAP audits and implement requirements for participating in the Medical Device Single Audit Program.
With these solutions, I help companies navigate regulatory challenges, pass regulatory audits, improve product quality, and comply with global standards.