Quality Management System
An effective quality management system is necessary and mandatory for companies developing and manufacturing medical devices. The most widely used medical device quality system standards are ISO 13485 and 21 CFR 820.
Quality systems are only effective when they are customised to the client’s requirements. No two companies will manage activities in the same way therefore companies need to take ownership of their quality system and make a system work for them rather than allow a system to dictate their activities. The other important aspect to consider in establishing or managing a quality system is to understand which parts of the system are required at each stage of the product development process. Medical device manufacturers who are applying for regulatory approval will need to address all elements of the quality system regulations but a company who are in the product development phase will only need functional document and design control systems.
Perficio Product Development can provide clients with ISO 13485 and/or 21 CFR 820 compliant quality system templates and can also advise clients, on how to customise the quality system to their needs, and how to introduce the quality system into the operational areas of their company. Perficio Product Development will not customise the quality system for the client as the quality system is only truly effective when the system ownership resides fully with the client.