Welcome to QS COMPLIANCE!

Quality Systems Compliance, LLC will help you achieve and maintain quality compliance, while meeting deadlines and containing costs. If you plan and implement your quality system correctly, it doesn’t have to be expensive to be in a state of compliance. In fact, implementing your quality system correctly the first time can reduce risk and liability. With the assistance of Quality Systems Compliance, LLC, you’ll implement a QUALITY SYSTEM plan that will make you compliant as well as profitable!

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ISO 9001-2015 and ISO 13485-2016 Certification
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 Mark Durivage
Preparing for an ISO Audit

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

26
Jan
certificate of Quality Systems Complaince Top 10 Medical Device Consulting Company 2019
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

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

30
Jul
A Military Tool For Pharma Vulnerability Assessment
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
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 Article by Mark Allen Durivage
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

About Us

Quality Systems Compliance LLC was founded in 2012 by Mark Allen Durivage. He saw an opportunity to serve the needs of businesses working in the FDA Regulated Industries including Medical Devices (21 CFR 820), Pharmaceuticals (21 CFR 211), Tissue (21 CFR 1271). He also provides services to non-FDA Regulated Industries which include ISO 9001 Quality management systems – Requirements, ISO 14001 Environmental management systems, IATF 16949 Quality management systems – Particular requirements for automotive production and relevant service part organizations, ISO 45001 Occupational health and safety management systems – Requirements with guidance for use, and ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories. The company specializes in Quality Compliance, Quality Assurance, Quality Systems, and Quality Control.

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Services

Auditing

Systems, supplies, storage, procedures, FDA and ISO regulation compliance auditing

Training

Quality control, systems and compliance training for medical facilities and FDA and ISO regulated industries

Consulting

Medical and pharmaceutical facilities, labs, food and tissue regulated environments through FDA and ISO business management consulting