The need for some form of a Quality Management System (QMS) has been a long-term requirement for Medical Device manufacturers.
Under the old regulations a certified Quality Management System was not specifically required for lower risk Medical Devices but manufacturers have always been obliged to have a manufacturing control function, and related procedures and records, particularly in respect of document control, traceability, vigilance and complaint reporting, and validation necessities.
Now the international standard ISO 13485 has become the gold standard for companies to work to and conformity to EN ISO 13485:2016 which has become expected and, particularly for higher class Medical Devices, to be separately certified by their Notified Body.
Class I medical device manufacturers and Class A IVD manufacturers should keep in mind that while a QMS is a mandatory requirement in accordance with Article 10 of both EU Regulations, a certificated QMS (e.g. audited by an accredited body) is not mandatory.
This Quality Management System standard describes the way a company should incorporate common sense control of their design processes, manufacturing, packaging, sterilisation and finish processing, and dispatch to the end user. In addition the standard discusses the need for post market activities through to the end the end of life of a medical device – Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF), so much that it is now considered as essential.
Under the new European Medical Device regulations, and In-Vitro Diagnostic Medical Device regulations, ISO 13485 is an important adjunct to demonstrate that company has control to meet its legal route and regulatory responsibilities, and in particular the need to comply to product liability requirements.
Advena specialise in the creation, of Medical Device Quality Management Systems for all manufacturing and related services.
