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 essential activity for regulatory compliance within pharmaceutical and medical device companies.  While it is often challenging for medical product manufacturers to incorporate risk-based principles into their quality and compliance approaches, it is essential that... 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