BSI Blog - Read all that our experts have to say!

Welcome to the BSI Blog.

Read all that our experts have to say in our latest blogs below or navigate straight to your chosen topic using the topics sidebar.

Welcome to the BSI Blog.

Read all that our experts have to say in our latest blogs below or navigate straight to your chosen topic using the topics sidebar.

What is the cost of good quality for medical devices?

In 2011, McKinsey & Co. published a study titled Quest for Excellence - Driving a Step Change in Medical Products Operations. It investigated quality-related costs across the medical device industry. These included day-to-day quality costs as well as costs and revenue losses from non-routine, poor quality events. A second study has been completed recently to update the analysis to identify the total cost of quality for medical devices. It focused on quality operations associated with manufacturing and did not assess quality costs in research and development or commercial activities. The study also investigated the emerging best practices in which medical device companies are investing resources.

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Canada announces modifications to the transition to the Medical Device Single Audit Program (MDSAP)

Changes to the transition process are intended to make it easier for manufacturers to switch to MDSAP. The MDSAP was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of quality management systems (QMS). Health Canada’s decision to replace the Canadian Medical Devices Conformity Assessment System (CMDCAS) and require an MDSAP audit to maintain Canadian Device Licenses is leading to a rapid increase in use of the programme. Health Canada expected manufacturers to submit a valid MDSAP certificate to the Medical Devices Bureau by December 31st, 2018.

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