EU In-Vitro Diagnostic Regulation (EU IVDR) 2017-746 Quick Reference

In-Vitro Diagnostic Regulation (IVDR) 2017-746 Quick Reference Regulation (EU) 2017/746 In Vitro Diagnostic Medical Devices [...]

Preparing for an ISO Audit

Preparing for an ISO certification, surveillance, or recertification audit can be daunting stress filled task, [...]

c=0 Sampling Plan Table

How To Establish Sample Sizes For Process Validation Using C=0 Sampling Plans By Mark Durivage, [...]

Understanding DOE’s Foundational Elements

Design Of Experiments 101: Understanding DOE’s Foundational Elements By Mark Durivage, Quality Systems Compliance LLC [...]

Is Your Personnel Hygiene Plan Up To Date?

By Mark Durivage, Quality Systems Compliance LLC Every organization that is regulated by the FDA [...]

Ranked on Top 10 List Medical Device Consulting Companies in 2019

Quality Systems Compliance named one of the Top Ten Medical Device Consulting Companies in 2019 [...]

How To Prepare For An FDA Inspection

How To Prepare For An FDA Inspection By Mark Durivage, Quality Systems Compliance LLC Every [...]

A Military Tool For Pharma Vulnerability Assessment — The CARVER + Shock Technique

By Mark Durivage, Quality Systems Compliance LLC Following the terror attacks of Sept. 11, 2001, [...]

FDA Proposes Program To Establish Voluntary Pharma Quality Standards

By Mark Durivage, Quality Systems Compliance LLC The FDA’s Center for Drug Evaluation and Research [...]

What Should You Do After An FDA Inspection?

What Should You Do After An FDA Inspection? By Mark Durivage, Quality Systems Compliance LLC [...]