Rich Wynkoop is a seasoned executive who takes a pragmatic approach to quality management, regulatory affairs, and compliance to achieve cost effective and successful outcomes. His experience spans world-class enterprises and multi-national organizations in medical device industries as a hands-on Quality Engineer, R&D Manager, QA Plant Manager, Director QA&RA, and Vice President QA&RA. This range of experience enables him to quickly target pragmatic solutions to difficult problems. Rich has also spent significant time preparing for and hosting regulatory audits and remediating difficult audit observations. He has designed and implemented Design Control, Software Validation, CAPA and other quality system elements that have stood up to robust examination by both Notified Bodies and FDA inspectors.
Importing Medical Devices into the United States
The import of medical devices into the United States is a crucial aspect of the healthcare industry. However, importing these products can be a complex process.
Medical Device Risk Analysis
Let's take a deeper dive into medical device risk analysis, including its purpose, process, and the FDA-recognized standard ISO 14971.
Vision28 Checklist for FDA FORM 483 responses
FDA Inspections, FDA FORM 483, and Warning Letters Medical Device Manufacturers