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Topics in Quality Assurance for Medical Devices
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Topics in Quality Assurance for Medical Devices

Publisher: FX Conferences
  • Description

Stay current on the ever-changing medical device regulatory environment with 10 audio recordings of industry experts offering practical guidance on quality assurance issues.

Ovid and FX Conferences offer thousands of professional development hours for your teams, conveniently packaged and delivered as a collection of audio recordings to save you time and money.

Topics in this collection have a global appeal and are relevant for multiple departments within your organization—R & D, Market Research, Compliance, and more. Each of the 10 recordings consists of a 45-minute, telephone-based presentation delivered by expert international speakers, followed by a 15-minute question-and-answer session (collection available with and without transcripts).


1. Revisions to EN ISO 14971 and 13485 – What Do They Mean for Device Manufacturers?
Speaker: Dan O'Leary, President, Ombu Enterprises

2. EU Medical Device Vigilance Reporting Requirements Under MEDDEV 2.12-1 Rev 7
Speaker: Helen Colquhoun, Senior Vice President, Cromsource

3. How to Document and Implement an FDA-Ready CAPA System
Speaker: Mark Perkins, Principal Consultant, Medical Device QA/RA Consulting

4. Risk Management Throughout the Medical Device Product Lifecycle
Speaker: Bill White, Senior Consultant, Quality System Strategies LLC

5. Device Master Records & Device History Records: Are You Compliant?
Speaker: Dan O'Leary, President, Ombu Enterprises

6. Regulatory Requirements for Medical Device Calibration Programs
Speaker: Dan O'Leary, President, Ombu Enterprises

7. Global Clinical Trials & ISO 14155: 2011 Compliance - Are Your Quality Systems Up to Date?
Speaker: Dr. Joy Frestedt, President & CEO, Frestedt Incorporated

8. Avoiding FDA 483s, Warning Letters and Recalls with Harmonized Supplier Qualification
Speakers: John Avellanet, Managing Director & Principal, Cerulean Associates LLC

9. Sample Size for Design Verification and Validation
Speaker: Steven Walfish, Statistician, GE Healthcare

10. Medical Device Design Requirements and Considerations for Risk Management
Speaker: Dan O'Leary, President, Ombu Enterprises

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