Webinar - Data Integrity of Medical Devices

The medical device industry is a strongly regulated business. Depending on the classification of the device, supervision from a Notified Body and partially from an authority is required. From the development of a medical device until the daily production and quality control, a lot of data come up, which can can be either generated manually or electronically. Besides, the data must be generated, handled and archived in such a way that the auditor/inspector has no objections to it. To assure this, the data management life cycle starts with the generation of data and ends with archiving or destructing. In the field of medical devices, only a few requirements from guidelines are available. There is an exception, though: the export of medical devices to the USA. In the USA, the compliance with 21 CFR 11 regarding the handling of electronic data is mandatory. Now, what can give some orientation for the EU market? What requirements are mentioned in ISO 13485? Could GMP rules for medicinal products/drugs also give hints for medical devices? All these questions and other items with focus on medical devices will be discussed during this webinar.

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