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ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
The Medical Devices Regulation (MDR (EU) 2017/745), replacing the MDD from 2021, requires information to allow the design stages applied to the device to be understood as part of the design and manufacturing information of a technical documentation for a medical device. ISO 13485 is a voluntary standard that contains section 7.3 Design and ...
The two have a great deal of similarity, and many manufacturers adopt QMS that is compliant with both guidelines. ISO 13485 are harmonized with the European Union Regulation 2017/745 as well as the IVD and AIMD directives. The ISO standard is also incorporated in regulations for other jurisdictions such as Japan (JPAL) and Canada (CMDCAS).
The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of a medical device to establish a technical file (medical device file, device master record, design dossier, or device master file). Annex II and III of the EU medical device regulation (MDR) and of the In-vitro Diagnostic Regulation (IVDR) contain an overview of the contents and ...
ModusLink Receives ISO 13485 Certification for Medical Device Manufacturers —Leading manufacturers of consumer-oriented medical devices certify ModusLink according to their ISO-based quality ...
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