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medical device single audit program | ISO Standards

Everything You Need to Know About the Medical Device Single Audit Program (MDSAP)

on 28 April 2021 | By Rem Siekmann, RQM+
Maintaining regulatory and quality compliance across multiple markets is challenging. In addition to meeting stringent regulatory requirements, manufacturers must also submit to regular quality system audits. When operating in multiple markets, this often means a busy audit schedule that can distract from daily operations.
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iso standards for medical devices | ISO Standards

Quick Guide to Medical Device Standards: ISO Standards and Beyond

on 28 April 2021 | By Rem Siekmann, RQM+
In the regulatory world, standards are essentially recommended processes that have been developed by subject matter experts with the aim of describing the best possible way to meet an end goal. For example, quality management standards are designed to improve efficiencies and avoid product failures.
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