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Providing Exceptional Quality Compliance Services to Meet Your Regulatory and Business Needs.

Over 20 years specializing in helping companies become compliant
with ISO standards and International Regulations
in the Medical Device, Biotech, and Pharmaceuticals Industries.

Healthcare Industry Compliance and Quality Consulting

Bringing a medical device or pharmaceutical product to market can be a challenging and complicated process, even for those familiar with regulatory requirements. Our team has over two decades of diverse quality assurance, engineering, and regulatory experience helping medical device, pharmaceutical, and biotechnology companies implement and maintain quality systems to achieve full compliance with U.S., Canadian, and European regulations and international standards.

At 80/20 Quality Consulting our mission is simple: to provide exceptional quality consulting services and help you meet your regulatory and internal business needs. Our comprehensive solutions are custom-designed to help you achieve and maintain regulatory compliance and commercial success.

Auditing

MDSAP, ISO 13485, ISO 9001, internal and supplier audits
FDA inspection/audit support

Regulatory Affairs

Compliance and regulatory strategy consulting
MDD to MDR assessment

Startup Assistance

Quality Management System implementation, audit readiness

Remediation

Quality System, GLP, and GMP gap assessment and improvement

Resource Enhancement

QMS Training, part and full time staffing support

Other Services

Stability studies, process and software validation and supplier evaluation

Pharmaceutical factory woman worker in protective clothing operating production line in sterile environment

Our consultant and 80/20 Quality Consulting did a great job on preparing us for ISO 13485:2016 audit. The consulting group is very professional and knowledgeable.

Renato Abrill
Quality Assurance Director, Lampire Biological Laboratories

2018-11-21T21:15:49+00:00

Renato Abrill
Quality Assurance Director, Lampire Biological Laboratories

Our consultant and 80/20 Quality Consulting did a great job on preparing us for ISO 13485:2016 audit. The consulting group is very professional and knowledgeable.

80/20 Quality Consulting has helped our organization with our FDA/ISO compliance by taking the time to understand what we do and how we do it. Their customized approach has helped us meet ISO 13485 regulations while streamlining our SOPs.

Mark Sutera
Senior Engineer, Surgical Tables

2018-11-21T21:10:30+00:00

Mark Sutera
Senior Engineer, Surgical Tables

80/20 Quality Consulting has helped our organization with our FDA/ISO compliance by taking the time to understand what we do and how we do it. Their customized approach has helped us meet ISO 13485 regulations while streamlining our SOPs.

The consultants at 80/20 Quality Consulting have been our consulting Quality Assurance and Quality Control specialists for several years now. Their knowledge of GLP, GMP, SOP and other FDA rules and regulations are extraordinary and exemplary. It was because of our consultant’s understanding of the FDA’s section 21 CFR, Part 58, Good Laboratory Practice for Non-Clinical Laboratory Studies that we are now totally GLP-compliant. I would recommend them, without hesitation, to anyone in need of a QA/QC Specialist.

James Staruk
President and CEO, Mass Histology Services

2018-11-21T21:18:02+00:00

James Staruk
President and CEO, Mass Histology Services

The consultants at 80/20 Quality Consulting have been our consulting Quality Assurance and Quality Control specialists for several years now. Their knowledge of GLP, GMP, SOP and other FDA rules and regulations are extraordinary and exemplary. It was because of our consultant’s understanding of the FDA’s section 21 CFR, Part 58, Good Laboratory Practice for Non-Clinical Laboratory Studies that we are now totally GLP-compliant. I would recommend them, without hesitation, to anyone in need of a QA/QC Specialist.

Our company was in a pinch to upgrade our ISO certification within a short timeframe. 80/20 Quality Consulting responded quickly and professionally. They guided us through the process, while taking a hands on approach to actually helping us get the paperwork done. They then provided an independent internal auditor because we didn’t have enough qualified people on our staff. It wasn’t easy, but the proof was in the outcome – an upgraded certification with zero findings! We will definitely have them help us with future work. I can’t thank them enough.

Mark Ensign
Executive Vice President, Cristcot

2019-03-28T17:42:42+00:00

Mark Ensign
Executive Vice President, Cristcot

Our company was in a pinch to upgrade our ISO certification within a short timeframe. 80/20 Quality Consulting responded quickly and professionally. They guided us through the process, while taking a hands on approach to actually helping us get the paperwork done. They then provided an independent internal auditor because we didn’t have enough qualified people on our staff. It wasn’t easy, but the proof was in the outcome – an upgraded certification with zero findings! We will definitely have them help us with future work. I can’t thank them enough.