Medical Products Consulting & Contracting Services
I work with established medical products companies and companies that are new to the space to implement and optimize their quality management systems (QMS) to best fit their business. My level-headed approach involves honest, open interactions with the FDA and ISO registrars in any circumstance.
Medical Products Consulting & Contracting Services
ISO 13485:2016 and FDA (21 CFR 820) Quality System Development (companies new to medical product space)
Implementation of Design Controls for technical teams
Training to various elements of FDA Design Controls and ISO 13485:2016 for technical teams and executives
International registrations/certifications of medical products with FDA and/or CE Mark
Quality Systems Optimization
Conversion of QMS to cloud-based solution
Audit/ inspection planning and execution
Optimization of QMS to better align with business processes
Alignment of IEC 62304 to ISO 13485 Design Controls
Risk Analysis including conversion of procedures to 14971:2019
Mitigations and Troubleshooting
Root cause analysis
Recall/complaint investigation and management
Audit/inspection response management
FDA response advisory