Why is ISO 13485 and Medical Device Testing so Important?

Consistent manufacturing quality is viewed to be critical to the safety and efficacy of medical devices. Medical regulatory bodies around the world, including the FDA, want to see processes and documentation that verify that a company manages the consistency of its manufacturing processes. ISO 13485 is aimed at ensuring a high level of consistency in the quality of manufacturing medical devices. It is typically combined with ISO 9001 to comprise a comprehensive ISO Quality System within a company.

Formal Process Validation involves Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). In Installation Qualification, each machine on the manufacturing line is installed correctly with proper connection to utilities and properly set up on the manufacturing line. Installation instructions are obtained from the equipment manufacturer. Documents are written to record these proper installation activities, including calibration certificates. Operational Qualification involves operating the machine as designed and instructed by the machine manufacturer to ensure that it performs the operations on the manufacturing line as intended. Performance Qualification involves examining variations in the operation of the machine due to normal process variation. This is often done by having three different operators run the machine in ostensibly the same way and documenting any difference in results.

What is 21CFR820 and How Does it Relate to ISO 13485?

CFR’s are Codes of Federal Regulations; that is, they are legal requirements in the USA. Title 21 of the Code of Federal Regulations (CFR) covers the broad area of food and drugs, as overseen by the FDA. Part 820 outlines the requirements for Quality Systems for medical device manufacturers; and Current Good Manufacturing Practice (CGMP) regulations that govern the manufacturing methods, facilities and production controls used in making medical devices. ISO13485 and 21CFR820 were “harmonized” a few years ago which clarified the legal requirements as to how companies are to make medical devices intended to be sold in the USA. Both involve Process Validation which involves IQ (Installation Qualification), OQ (Operations Qualification) and PQ (Performance Qualification).

TestResources test equipment is often needed for in-process tests within a validated medical device manufacturing process. A common example of this process would be qualifying each manufacturing lot of sterile package seals. TestResources can help you formally validate our equipment for your process by providing advice, IQ checklists, and other relevant documentation. We can also help you with appropriate checklists and documentation if you find it valuable to perform a formal gauge R&R assessment on your TestResources test equipment.

TestResources understands the medical device manufacturing industry and has provided assistance to several companies, including Medtronic, with their ISO 13485 process. Our test machines are highly successful in these IQ, OQ, and PQ qualifications, as well as Gauge R&R activities. Our engineers are aware that the ISO 13485 validation process is time-consuming and fast-paced. Knowing that your schedule is urgent, our engineers are ready to advise and assist you in validating your manufacturing process quickly. What sets us apart is that our engineers are the first to receive your call and can immediately provide you with your free testing advisement today. Give us a call now for help with your ISO 13485 testing.

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