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The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
A NEW Member Benefit for 2021
Welcome to the fall issue of RF Quarterly in which international experts from the US, EU, and Saudi Arabia examine quality and compliance and their governing regulations, with specific focus on data integrity, quality system design and management, current good manufacturing practice, and postmarketing activities in relation to medical devices, pharmaceuticals, and biologics.
1 Introduction: Quality and compliance
4 Data integrity and compliance with GxP: A pragmatic approach
David W. Husman, PhD, ASQ CPGP, RAC
19 Current good manufacturing practices and quality system design
Joscelyn Bowersock, MS-RA, and
Richard Vincins, CQP, MCQL, CBA, CQA, RAC
41 Medical device quality management systems
Gert Bos, MSc, PhD, FRAPS
54 Medical device compliance and postmarketing activities
Ryan Burke, RAC and Elizabeth Goldstein, RAC
68 PMS and the role of CAPA in the medical device regulatory cycle:
A Saudi perspective
Mohammed Majrashi, PhD
72 Biologics compliance
Anne Marie Woodland, MS, RAC
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