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Adapting to the new normal: third-party audits

Published: 24 Feb 2021

Damien Tiller, CQP MCQI, IRCA Lead PQMS and QMS Auditor, highlights the way the SOC® Service Organizations: Trust Services Criteria Report could overcome the difficulties inherent in remote auditing.

The evolving role of quality risk management

Published: 12 Oct 2020

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

Published: 4 Jun 2020

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.

Are your suppliers prepared for the revised ISO 13485?

Published: 5 Feb 2018

Werner Karau, European Commercial Leader at Flexan LLC, analyses why original equipment manufacturers (OEMs) must ensure their suppliers comply to the revised ISO 13485 standard by the March 2019 deadline