Items Tagged with 'ISO 13485'

ARTICLES

2025 Quality Rookie of the Year, Attrayee Chakraborty with the Rookie of the Year logo and a blurred background.
A Relentless Pursuit of Excellence

Meet the 2025 Rookie of the Year: Attrayee Chakraborty

Attrayee Chakraborty is a quality professional in the medical field, with a biotechnology background and expertise in AI.
Michelle Bangert
Michelle Bangert
April 29, 2025

Quality is honored to name Attrayee Chakraborty as our 2025 Quality Rookie of the Year. Discover how she earned the award through her groundbreaking work in medical device quality and AI integration.


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01 QM 1223 Management feature opening image of two quality personnel in hard hats
Management

An ISO Auditor’s Advice for Internal Auditors

The key to a solid internal audit is ensuring that those in the process are aware of the requirements noted in their procedures and can access those procedures.
Daniella Picciotti
November 30, 2023

Tips to take the mystique out of the internal audit process. The examples provided give you insight into the 3rd party auditor’s perspective.


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Medical Devices

Medical Devices

ISO 13485 places new emphasis on risk management.
EdwardMcMenamin_200
Edward McMenamin
October 1, 2016

New changes to ISO 13485, published this spring as EN ISO 13485:2016, mean U.S. medical device companies that sell in Europe will need to integrate risk-based approaches throughout their quality management systems. The emphasis on risk management is the biggest of several changes in the third version  of ISO 13485.


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