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From:Medical Product Outsourcing (Vol. 19, Issue 3)In recent years, medical device manufacturers have faced rapidly evolving expectations about conducting biocompatibility testing to support preclinical product safety testing. With the recent changes to ISO 10993, the...
From:Medical Product Outsourcing (Vol. 19, Issue 1)The pressure to increase efficiency in medical device development has been prevalent across the industry over the past year, especially with the intensified regulatory expectations. Many projects continue to experience...
From:Medical Product Outsourcing (Vol. 17, Issue 8)As the EU medical device regulation (MDR) deadline draws near, medical device manufacturers are increasingly under pressure to bring products into compliance and get submissions in front of regulators as soon as...
From:Medical Product Outsourcing (Vol. 18, Issue 4)The beginning of 2020 has left the industry strained and delayed implementation of the Medical Device Regulation (MDR) by one year (May 2021). Regardless of where a manufacturer's product portfolio currently stands,...
From:Medical Product Outsourcing (Vol. 18, Issue 9)From supply chain disruptions to impromptu manufacturing modifications, the medical device industry has faced a whirlwind of complications in 2020. While many in the industry are working in overdrive to keep projects on...
From:Medical Product Outsourcing (Vol. 17, Issue 6)With recent updates to ISO 10993-1 and the Medical Device Regulation (MDR) on track to replace Europe's current Medical Device Directive (MDD) next year, European medical device requirements present greater regulatory...
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