ISO 13485 and ISO 9001 for Medical Devices…The Difference? (Part 2)
QMS…? ISO 13485 adds to the requirements of ISO 9001 by demonstrating responsibility for “maintaining the effectiveness of the quality...
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Tim
Dec 4, 20222 min read
ISO 13485 and ISO 9001 for Medical Devices…The Difference?
What's the difference between ISO 13485 and ISO 9001? Do you need to adhere to both or just one of them? Electronic Quality Management...
Tim
Mar 16, 20224 min read
Understanding Technical Documentation in EU Regulations
The content below is a highly recommended article about specific information concerning how your QMS and EU-MDR/EU IVDR will impact your...
Tim
Feb 1, 20229 min read
What Is Non-Conformance And How to Minimize It
Non-conformance means that something went wrong with a process, service, or product, and the result doesn't match the initial specifications
Tim
Nov 8, 20213 min read
Top 5 Reasons Quality Management Systems Fail
Your Quality Management System can become overly complex over time due to excessive layers of unneeded documents, procedures, forms, etc..
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