FDA 21 CFR Part 820 Quality System Regulation
FDA 21CFR part 820 is regulation from FDA which outlines cGMP requirements with regards to quality system. To sell medical devices in the US market you need to be 21CFR 820 Complaint and in this process our team can guide you. We provide QMS solutions which will help you to get aligned with new regulations and standards.
What is FDA 21 CFR Part 820 Quality system Regulation?
Let’s understand first CFR, CFR is code of Federal in which 21 is title and 800 represents the series which is for medical devices and 820 is for quality system regulation (QSR) on which we are spreading light.
FDA 21 CFR Part 820 medical device covers the processes used in, & the facilities & controls used for the design, manufacture, packaging, labeling, storage, installation & servicing of medical devices. Manufacturers are inspected by US FDA as per Part 820, however, there is no certification process for Part 820 & only compliance with the requirements is assessed.
FDA QSR Compliance for medical device manufacturers:
As we know 21CFR part820 is part of cGMP I.e Current Good Manufacturing Practices regulations. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as Current Good Manufacturing Practices. cGMP requirements for devices in part US FDA 21 CFR Part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act, FDA 21 CFR part 820 (QSR 21 CFR part 820 is USFDA current good manufacturing (cGMP) requirements for medical device manufacturers.
The FDA 21 CFR part 820 also known as Quality System Regulation i.e., FDA QSR which outlines current good manufacturing practice (cGMP) regulations that control the techniques used in and the efficiency and controls used for, the manufacturing, labelling, packaging, storage, installation, design, and servicing of all finished medical devices predetermined for human use and marketing in the United States of America. The above requirements are turned to ensure that medical devices are safe and effective produced by medical device manufacturers who support FDA (Food and Drugs Administration) inspections to assure FDA QSR (quality system regulation) 21 CFR part 820 compliance.
Looking for Consultant?
Why should you care about 21CFR part820?
Medical device manufacturers should take care of 21 CFR part820 regulation because if they are found to fall short of minimum standard in the inspection process, they might receive warning letter from FDA. This can be a huge reputational damage and can negatively impact on your market performance. When you are importing devices from US to Oman to place in market it is advisable to check whether they are fulfilling the QSR requirement or not.
Our role in FDA 21 CFR Part 820 – Quality System Regulations:
Are you prepared to sell your medical devices in the United States? Provided that this is true, your organization must conform to the US FDA QSR (Quality System Regulation), particularly known as 21 CFR Part 820. Regardless of the possibility that you as of now have a quality management system must meet this regulation before you can sell your device. When you are producing devices in Oman and want spread wings in Oman market you may need to fulfil the requirement set by Oman market and to complete these requirements our team will guide you through whole process of compliance.
Operon Strategist does an initial gap analysis of the existing system to determine the extent of development of the quality system. We provide 21 CFR 820 training courses in which we guide the clients through documentation & help them to effectively implement it through the various functions of the company. We also conducted a mock audit to test the effectiveness of the implementation of Part 820 requirements. We also provide post-inspection guidance to clients to help them close any non-conformance observed during the audit. FDA 21 CFR Part 820 helps manufacturers to build and follow quality systems to help assure that their products consistently meet applicable requirements and specifications.
Why Choose Operon Strategist?
Operon Strategist is FDA 510 k Clearance consultant and helps the clients to register SBU (Small Business Unit), if applicable. Take out the testing requirement of the product, creation of the dossier, resolving the queries and after completion of all the activities, the client receives the US FDA 510 k approval.
We are a medical device consulting firm assisting companies and medical device manufacturers by providing consultancy services that support the registration of drug-device combination products. We have experience with each constituent part and the GMP regulations that together form the basis for their development and manufacture: Drug (21 CFR 210 and 211), Device (FDA 21 CFR part 820) and Combination Products (21 CFR Part 4). Our experience and work methodology differentiated us from others. To know more details and to avail ourselves of our services you easily contact us.