Looking for FDA Regulations Consulting in Indiana?

Quality Systems Compliance, LLC and Mark Durivage specialize in FDA, ISO and Quality Systems auditing, training and consulting for the medical and auto industries, and organizations involved with tissue and food.

We provide FDA Regulations Consulting in Indiana, across the U.S., and internationally.

Please visit our Home page to begin learning more about Consulting and other services provided by Quality Systems Compliance, LLC. We look forward to helping your organization meet your FDA Regulations goals in a quick, cost-effective manner.

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Quality Systems Compliance, LLC Now Certified for ISO 9001:2015 and ISO 13485:2016

We’re pleased to announce Quality Systems Compliance, LLC has recently been awarded certifications for maintaining [...]

10
Nov

Preparing for an ISO Audit

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

26
Jan

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 [...]

19
Nov

How To Prepare For An FDA Inspection

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

30
Jul

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, [...]

13
Jun

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 [...]

14
May

What Should You Do After An FDA Inspection?

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

11
Apr

How Much Do You Know About MDSAP?

  A full Medical Device Single Audit Program (MDSAP) Audit is comprised of seven chapters, [...]

24
Apr