top of page

FDA QSR: Compliance for Medical Device Manufacturers

What Is It?


The FDA QSR is a set of Quality System Regulations defined by the U.S. Food & Drug Admission. All medical device manufacturers are required to establish and maintain a quality system that meets the legal requirements prescribed in 21 CFR Part 820. Under this legislation, there are 14 subparts to ensure quality and safety throughout the design and manufacturing process of the medical devices:


  • General Provisions

  • Quality System Requirements

  • Design Controls

  • Document Controls

  • Purchasing Controls

  • Identification and Traceability

  • Production and Process Controls

  • Acceptance Activities

  • Nonconforming Products

  • Corrective and Preventive Action

  • Labeling and Packaging Control

  • Handling, Storage, Distribution and Installation

  • Records

  • Servicing

  • Statistical Techniques

What Does It Do?

By achieving the FDA QSR compliance, manufacturers can ensure that their medical devices are legally eligible to be sold in the United States and conform to applicable requirements and specifications. This also acknowledges good manufacturing practices and quality management of your organisation.


Why Choose Us?


Wiselink Medical is committed to provide reliable consultancy and efficient services with exceptional knowledge, experience and expertise. We have an international team with a pool of experts from Australia, United States, Canada, Europe and China, who have more than 20 years of industry knowledge to offer you the most efficient and cost-effective solutions.

bottom of page