Medical Device Quality Management Systems that are Efficient, Effective, Sustainable, Usable, and Compliant. Winovia can help you get there.
Consulting and training specialties include:
- Leading remediation projects; functioning as the acting or interim Director of Quality Systems
- Product life cycle management; new product development processes; Design for Six Sigma, Design Controls
- Manufacturing and operational excellence, Six Sigma and Process Validation
- Supplier Controls / Supplier Quality
- Corrective Action and Preventive Action (CA/PA)
- Strategic Technology Road-mapping
- Quality Management Systems and good manufacturing practices (FDA 21 CFR Parts 210, 211, 820; ISO 13485; ISO 9001; ISO 16949; ICH Q7 and Q10)
- Change Control
- Risk Management (ISO 14971, ICH Q9, HACCP, FTA, FMEA)
- Change Management
- Project Management
- Plastics in Medical Devices
For occasional updates on trainings, conferences, and news articles, join our Email List. We will never share your information.