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How will ISO 13485:2016 impact your relationship with suppliers?
The importance of the "risk based approach" for the correct performance and adequate safety of medical devices.
Informazioni sul contenuto
The new ISO 13485:2016 encompass high impact changes for the industry of medical devices. The new standard will demand new ways of interaction with suppliers, required mainly by the "risk based approach".
In this article, Walt Murray discusses the importance of the "risk based approach" for the correct performance and adequate safety of medical devices. He also clarifies the changes of the new 13485:2016 standard, and how this impacts the relationship between medical device makers and suppliers.
Informazioni sull'autore
Walt Murray
Walt Murray, ICLA, CSSMBB, president and CEO of ARC Experts is a globally recognized compliance and risk consultant. With more than 32 years of experience working with highly regulated companies, Murray is a CQEH&S Lead Auditor and is certified in quality and environmental systems auditing (AQS Systems), Critical-Thinking Skills (CTS – K-T/Alamo Learning Systems) and process control and improvement (Deming Certification). He has performed more than 400 audits for a variety of Fortune 500 life sciences companies and hosted investigational and systems audits by the FDA, Therapeutic Goods Administration (TGA), Medicines and Healthcare Products Regulatory Agency (MHRA) and Health Canada (HC/CMDR).
