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The U.S. Food and Drug Administration (FDA) has established 21 CFR Part 820 regulations for medical device manufacturers to ensure the safety and efficacy of finished devices. To prevent dangerous medical products from harming consumers, the FDA protects the health of the public by enforcing laws and regulations within the United States of America. The quality system (QS) regulation 21 CFR Part 820 provides the good manufacturing practice (GMP) requirements that medical device manufacturers must comply with. The QS regulation applies to finished device manufacturers who intend to commercially distribute medical devices. Our consultants can help your organization establish a quality system to ensure compliance with 21 CFR Part 820 regulations.


Contact us today to learn more about our 21 CFR Part 820 compliance consulting services.

Benefits of 21 CFR Part 820 Compliance

• Comply with medical device laws and regulations

• Ensure the safety and efficacy of medical devices

• Prevent dangerous or defective products from causing harm

• Reduce consumer risks

• Avoid costly recalls and lawsuits

• Ensure consumer safety


How We Can Help

The ISO 9001 Group understands 21 CFR Part 820 regulations and how to comply with them. We can assist with:

• FDA registration

• Consulting

• Designing a 21 CFR Part 820 quality system

• Implementation

• Audits and inspections

• Responding to FDA warnings letters

Our consultants will work with you to implement the applicable FDA medical device regulations to ensure effective, efficient and compliant operations. Our proven, hands-on approach provides confidence that your organization will be in compliance with FDA regulations.


21 CFR Part 820 Overview

21 CFR Part 820. Quality System Regulation

Subpart A – General Provisions

Subpart B – Quality System Requirements

Subpart C – Design Controls

Subpart D – Document Controls

Subpart E – Purchasing Controls

Subpart F – Identification and Traceability

Subpart G – Production and Process Controls

Subpart H – Acceptance Activities

Subpart I – Nonconforming Product

Subpart J – Corrective and Preventive Action

Subpart K – Labeling and Packaging Control

Subpart L – Handling, Storage, Distribution, And Installation

Subpart M – Records

Subpart N – Servicing

Subpart O – Statistical Techniques

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