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Preparing for unannounced audits of medical devices
ISO 13485 internal auditor Karandeep Singh Badwal, explains what to expect and how to prepare for unannounced audits of companies with a UKCA or CE-marked medical device.
How QMSs can ensure safety in medical devices
Karandeep Singh Badwal, Director of QRA Medical and an internal auditor for ISO 13485, outlines some of the common mistakes found in the quality management systems for medical devices.
Achieving accreditation as a small company
Su Chantry, Clinical Director at SKC Occupational Health, outlines her journey to ISO 15189 accreditation.
Maintaining quality standards in disruptive times through internal audits
Youmna Abboud, Quality Assurance and Regulatory Affairs Associate at Zimmer Biomet, Middle East, explains why internal audits are required during the coronavirus pandemic.
The evolving role of quality risk management
Jayet Moon, CQP MCQI, Quality Engineering Lead at Terumo Medical Corporation, US, and Veronica Cavendish-Stephens, Principal at Auchincloss-Stephens, explains how quality risk management is developing in line with business responses to Covid-19.
Keeping up with supplier demand
As the coronavirus pandemic continues, Jennifer Feasby, Quality Manager at Hart Biologicals, UK, speaks to Daniel Moore about how the company has continued to supply In Vitro Devices to customers, while tackling the challenges and threats posed by Covid-19.
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