MDPharmaCourses | Regulatory, Quality and Compliance Training

GD&T Geometric Dimensioning & Tolerancing Presentation Webinar Register Now! Description: GD&T is a system of symbols and features used in machining, manufacturing, quality and design that specify the shape, orientation, size, and critical features of the object of the drawing. GD&T is used to ensure that everyone is on the same page regarding how a feature or part is defined. This training will introduce to the basic concept and provide the necessary…

MDPharmaCourses | Regulatory, Quality and Compliance Training

WEBINAR TRAINING – TRADITIONAL 510 K – FDA REGISTRATION – REGULATORY (Buy Ticket Now) Download the course Brochure Availability: Right Now (Recorded Presentation) Duration: 30 min. (the average time to complete the training program). Description: This webinar course will describe how to manage a new Traditional 510k, providing description of the details to include in each Section of the application. The specific points that will be treated in the webinar are: When a…

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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…

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