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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.