Digital Continuity: Strategies for Product Recall Resilience The mission to bring meaningful innovation to market and improve patient lives is paired with the requirement that such innovations are held to the highest quality. There were 70 class I U.S. medical device recall events in 2022, a category that the FDA reserves for problems that …
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Ask the Expert: Improving Sustainability in Medical Device Manufacturing With a growing focus on climate commitment, MedTech companies are examining how their products are repaired, refurbished and recycled. The Health Solutions team at Flex is partnering with them on their sustainability journey to develop and implement tailored circular solutions to prolong a product’s life …
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Ask the Expert: Benefits and Challenges of the eStar Submission Process As of October 1, 2023, all U.S. FDA 510(k) submissions, unless exempted, must be submitted as electronic submissions using the eSTAR platform. In this column, Dr. Dhriti Roy, vice president of Regulatory Affairs Transformation at Essenvia and faculty at Oxford University’s MedTech innovation …
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Ask the Expert: Four Key Reasons Medical Device Manufacturers Should Be Looking at Mexico With the increasing global need for medical care and greater pressure on the healthcare system as people live longer, the medical device manufacturing industry has significant opportunities for growth. But with this growth potential comes increased competition and a need …
Ask the Expert: The Impact of IVD Regulations on Manufacturing In vitro diagnostic (IVD) devices are medical devices used to perform tests on human specimens such as urine, blood, or tissue, to help diagnose diseases or monitor health conditions. IVD devices play a crucial role in healthcare, as they enhance accurate diagnoses and treatment …
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Ask the Expert: EU MDR as a Trigger for Innovation Much of what has been written about the EU MDR emphasizes the increased regulatory burden that it puts on medical device companies. Giotto Compliance looked at the bright side of the new regulations and viewed EU MDR requirements as a catalyst to drive innovation …
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Raising the Bar on Quality for MedTech Production Quality is a cornerstone in the production of medical devices. It is fundamental to the success of a business and to the patients that use the devices. Yet, traditionally, it is also one of the biggest cost overheads for manufacturers. The way we approach quality, however, …
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