Blog

View the most recent blog posts.

Experienced manager of quality assurance and regulatory affairs staff for new product development
Regulatory compliance for the commercial production for device, drug and combination products for worldwide markets
Subject matter expert in managing design control requirements for 20+ medical device and combination products from concept to launch following 21 CFR Part 4, 211, 820, ISO13485, EU MDR, and worldwide regulatory requirements
Subject matter expert in creating supplier quality processes utilizing a risk based approach in the management of an approved supplier lists
Implemented 21 CFR Part 4, 11, 211, 212, 820, and EU MDR regulations in organizations for drug-device and device-drug combination products

Do you want to know more?