webinar trainings - mdpharmacourses · new iso 13485:2016 - qms transition training – live...
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MDPHARMACOURSES.com
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Certification Requirements: Students must view the entire program and successfully pass an online, multiple choice final assessment with >80% passing grade.
Certificate will be printable in PDF format immediately after satisfying requirements.
Online Training Programs Include: • Answer to questions submitted during the Webinar. • An online final assessment with multiple-choice questions. • A Certificate of Completion.
Course Presented and Commented by: Ing. A. Ravizza
NEW ISO 13485:2016 - QMS TRANSITION TRAINING – LIVE WEBINAR – 21 JULY 16 – 20:30
Description: This 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 provides an effective framework to meet the comprehensive requirements for a medical devices quality management system; for manufacturers and service providers to both comply and demonstrate their compliance to regulatory requirements.
ISO 13485:2016 supports the design of a quality management system that establishes and maintains the effectiveness of a manufacturer’s processes to ensure the consistent design, development, production, installation, and delivery of medical devices, or related services, that are safe for their intended purpose.
The new edition is applicable across the whole supply chain and seeks to address the entire lifecycle of a medical device.
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Early bird booking Promotion: Register now and get 25% Off!! – (Valid until 30/06/2016). Send email to [email protected] to get the discount code.