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Quality Assurance

Create Quality Management Systems that align with existing business processes while achieving compliance with 21 CFR 820 and ISO 13485.

Determine QMS Requirements

Review Existing Procedures

Create  or Update Procedures for 21 CFR 820 and ISO 13485 Compliance

Tablet pc device with connection lines on screen in hands of doctor
Quality Assurance

At Folio Consulting Group, LLC we can help create or review your Quality Management System to ensure compliance with 21 CFR Part 820 – FDA’s Quality System Regulation, ISO 13485:2016 – Medical devices – Quality management systems, and ISO 14971:2019 – Medical devices – Application of risk management to medical devices.


We have provided consulting support for clinical, usability, engineering, manufacturing, and supply chain teams to ensure compliance through the design control and manufacturing process. We offer quality assurance expertise during design input & output creation, verification, validation, design transfer, pre-clinical, and clinical testing. No matter what stage of development you are in, reach out to us for a free 30-minute initial consultation to discuss how we can assist with your quality management system.

We handle the detailed QMS compliance review so you can concentrate on your business.

Are you pressed for time?

Reach out to discuss our priority project pricing.

With a deep understanding of regulatory requirements, we make premarket submissions easy.

Click to schedule a free 30 minute initial consultation to see how we can help craft your regulatory strategy. 

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