Ultimate Guide on FDA QSR Compliance for medical device manufacturers

QSR Compliance : 

The medical device industry in the US is highly regulated, as medical product supplied can pose a great threat to the health and safety of humans. The US FDA is the leading regulatory body in the world that has established certain frameworks and regulations to which the medical device manufacturers need to be compliant with for their approval or clearance. FDA has set Quality System Regulation (QSR) specifying current Good Manufacturing Practices (cGMP) for medical devices in the industry. Manufacturers developing and supplying medical devices to the U.S. are expected to maintain these stringent quality management systems and be compliant with the code of Federal Regulations 21 CFR 820. Here the system covers a broad range of areas, including production and process controls, Corrective And Preventive Actions(CAPA), product development and management. Manufacturers must adhere to quality systems and ensure that their products consistently meet the requirement as specified by the FDA. Manufacturers supplying medical devices to the US must have complete knowledge and understanding of the regulations and QSR compliance pertaining to medical devices.  Since the medical device industry in the US is compliance and regulation-driven industry, the manufacturers must be aware of various medical device regulations and frameworks.

Medical Device Regulations for manufacturers supplying to the US

In the US, medical devices are regulated by the Food and Drug Administration (FDA) to ensure complete safety of the devices. Here the quality regulation requirements as specified in FDA 21 CFR Part 820 (which is also known as the Quality System Regulation QSR) are broadly pertaining to the methods, facilities, and controls used for the entire medical device, including the purchasing, designing, manufacturing, packaging &labelling, storing, installing and servicing of the devices intended to be used on humans. The FDA mandates emphasise on following quality system requirements for all medical devices seeking for approval. This ensures that the manufacturers meet all the statutory requirements and specifications consistently before supplying their devices to the US.

The FDA’s quality system which is named as Current Good Manufacturing Practices (cGMPs) and forced under part 820 (21 CFR part 820), is authorized by section 520(f) and came to be effective from December 18, 1978. Considering the range of medical devices, the regulation authority simply provides a framework that manufacturers need to follow in order to comply with the regulation. They do not provide any specifications of how the device needs to be improved or made as such. Further, to ensure that all the regulatory norms and requirements are adhered to, the FDA inspects all manufacturing facilities as well. Every manufacturer is responsible for abiding by all the regulatory requirements for making the medical devices safe and effective, irrespective of their type and use in the industry. This FDA regulation applies to all manufacturers producing the finished medical device and supplying the devices within an intention to commercially distribute them in the United States. A finished device is an equipment that is suitable for use, irrespective of whether or not they are labelled, packaged, or even sterilized.

Quality System Requirements to be adhered to as per the US Code of Federal Regulations

As stated before, adhering to Quality System Requirements is a necessity for any manufacturers supplying medical device with an effort to commercialize it. For medical device manufacturers seeking regulatory clearance or approval in the US need to comply with 21 CFR Part 820 of the US Code of Federal Regulations to bring their products to market. Currently, the Quality system requirements of 21 CFR Part 820 explains that the manufacturers need to comply with regulations in the following areas namely:

• Management responsibilities
• Internal quality audits
• Personnel qualification and training
• Design controls
• Document and purchasing controls
• Identification and traceability
• Production and process controls
• Process validation
• Acceptance Activity
• Non-Conformance of Product
• Corrective And Preventive Action(CAPA)
• Labelling and Packaging
• Servicing
• Statistical Techniques

Read More -  QSR compliance

Visit Us - Medical device consulting

Read More Article - 

1. Orthopedic Implants Manufacturing
2. Dental Implants Manufacturing
3.Blood Collection Tubes Manufacturing
4. How to start the Manufacturing of Disposable Syringes?

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device