AAMI Has Just Released an Important Document Mapping US 21CFR 820 to the Medical Device Standard ISO 1348

Teresa Gorecki |

Are you a device or combination products manufacturer or service provider? AAMI has just released an important document mapping US 21CFR 820 to the Medical Device Standard ISO 13485. If you have not started or are behind in... Read more

How Quality Records and Documents Create Your Biggest FDA Inspection Risk

Jack Garvey |

Risk management is an integral part of regulatory compliance for the pharmaceutical and medical device industries. While quality regulations for medical product manufacturers don’t always incorporate risk-based principles, creating compliance-implicated documents that the FDA reviews during an inspection should. ... Read more

Why Is There A Lack of Connection Between FDA Inspection Results and True Quality Outcomes?

Teresa Gorecki |

After decades in the pharma, device, and biologics industry working in new product development quality; manufacturing quality; market quality and post market surveillance; and quality systems my answer can be summed up in one word. Watermelon. yes, watermelon.... Read more