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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Medcrypt Appoints Former FDA Officer to Vice President of Services Naomi Schwartz, former premarket reviewer and consumer safety officer for the FDA, has been promoted to serve as Vice President of Services at Medcrypt, a cybersecurity solution provider for medical device manufacturers. In this new role, Schwartz will provide regulatory guidance to medtech companies …
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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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Cordance Medical’s NeuroAccess Receives FDA Breakthrough Device Designation The FDA has granted NeuroAccess from Cordance Medical, a medical device company focused on opening the Blood-Brain Barrier (BBB) to facilitate liquid biopsy, Breakthrough Device Designation. The NeuroAccess device is indicated for adult patients (aged 22 and above) who have received a known or highly suspected …
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FDA Publishes Final Guidance on Assessing Credibility of CM&S in Device Submissions The FDA has published its final guidance Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. The final guidance provides a framework that manufacturers can use to show that computational models used to support regulatory submissions are credible. It …
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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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The Drivers Boosting Medtech Investments in Cloud-based Digital Transformation This year, revenue from the medtech market is expected to reach $571 billion, according to Statista. The largest segment—medical devices—will reach a projected market volume of $472 billion. As with most industries experiencing steady growth, the medtech market faces several challenges, including supply chain issues, …
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EU MDR: Ensuring Labeling Compliance In July 2023, the European Parliament granted an extension to the new European Union Medical Device Regulation (EU MDR). This extension acknowledges the challenges that have arisen due to slow market readiness and lack of notified bodies, and grants companies additional flexibility to meet the demand for safe, innovative …
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 …
CDRH Releases List of Proposed 2024 Guidance Documents Change control plans for AI/ML, remanufacturing of devices and medical device shortages are among the guidances the FDA Center for Devices and Radiological Health (CDRH) is prioritizing in 2024. On October 10, CDRH published a list of guidance documents it intends to publish in the coming …
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