Iso 13485 Medical Device File

With the addition of sub clause 4 2 3 regarding medical device files in iso 13485 2016 the standard has brought increased value for implementing organizations.

Iso 13485 medical device file.

Will technical documentation reviews. Medical device files were not required in the earlier edition of the international standard i e. It can also be used by internal and external parties such as certification bodies to help them with their auditing. Who is iso 13485 for.

Iso 13485 2016 combines the dhf dmr and other documentation into a file known as the medical device file device history record dhr continuing our cooking analogy the device history record dhr is demonstrable proof that you followed the recipe namely your dmr. Iso 13485 2016 standard requires meddev organizations to establish and maintain one or more medical device files. What type of file does medical device file refer to. Iso enabled free access to iso 13485 and other medical device and protective clothing standards.

Iso 13485 topic iso 13485 qms. That implies for each medical device type or medical device family either containing or referencing documents as a proof for conformity to the requirement of this international. If any requirement in clauses 6 7 or 8 of iso 13485 2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied the organization does not need to include such a requirement in its quality management system. A medical device is a product such as an instrument machine implant or in vitro reagent that is intended for use in the diagnosis prevention and treatment of diseases or other medical conditions.

Medical device file refers to both the device master record and the technical documentation technical file or design dossier. Liza horielikova april 14 2020. To support the initiatives dealing with the impact of covid 19 the international organization for standardization iso has made some of its standards supporting biological evaluation of medical devices and. It s required by fda but iso 13485 2016 contains no such requirement.

Iso 13485 is designed to be used by organizations involved in the design production installation and servicing of medical devices and related services. The medical device files are documented guidelines. The requirements of this clause were previously documented in clause 4 2 1 in iso 13485 2003 and en iso 13485 2012.