MDPharmaCourses | Regulatory, Quality and Compliance Training

Live Webinar: Drafting of the Biocompatibility report in accordance with ISO 10993-1 – 15 SEP 17 Duration: 50 min. + 10 min. Questions Time. Register Now! Download the Course Brochure   Description: ISO 10993-1:2009 describes: the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of devices based on the nature and duration of their contact with the body; the evaluation of existing relevant…

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ISO 13485:2016 – Transition Training – Recorded Live Webinar Register Now! Download the Brochure This recorded live webinar course will provide guidance on how to perform the transition to the Medical Device Quality Management System (QMS) Standard ISO 13485:2016. In Particular will discuss the following points: 1. Comparison with previous version of ISO 13485 2. Impact on existing QMS 3. Consistency with new ISO 9001:2015 4. Regulatory impact The new ISO 13485:2016 standard…

CLINICAL EVALUATION OF MEDICAL DEVICES (Buy Ticket Now) Download the Course Brochure Availability: Right Now (Recorded Presentation) Duration: 70 min. (the average time to complete the training program). Description: This course provide a guideline on how to prepare a clinical evaluation for a Medical Device, considering the applicable laws and standard, providing example and also a guideline in setting up a SOP for the conduction of clinical evaluation. An overview of discussed topic is…