MedAccred Logo

PRI Establishes Working Group to Improve Medical Device Quality and Supply Chain Resiliency

The Performance Review Institute (PRI) has convened a new working group comprised of representatives from the medical device industry, government, and industry associations to identify and recommend best practices to…

The Performance Review Institute (PRI) has convened a new working group comprised of representatives from the medical device industry, government, and industry associations to identify and recommend best practices to…

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Michael King
Soapbox

Tackling Go-To-Market Challenges

By Michael King

…and China where local product testing, toxicological testing and clinical activities may be required (and assuming all goes to plan). Subscribe to the MedTech Intelligence weekly newsletter to stay up…

…and China where local product testing, toxicological testing and clinical activities may be required (and assuming all goes to plan). Subscribe to the MedTech Intelligence weekly newsletter to stay up…

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Scott Longval

Intricon Launches Biosensors Center of Excellence

By MedTech Intelligence Staff

Intricon, a developer and manufacturer of medical devices powered by smart miniaturized electronics, has launched a new Biosensors Center of Excellence (CoE). The center combines the company’s biosensor device expertise…

Intricon, a developer and manufacturer of medical devices powered by smart miniaturized electronics, has launched a new Biosensors Center of Excellence (CoE). The center combines the company’s biosensor device expertise…

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Danny Wilson
Ask the Engineer

Best Practices and Pitfalls When Going from Concept to Commercialization

By Danny Wilson

…way. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device development and regulation. A common condition known as…

…way. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device development and regulation. A common condition known as…

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FDA Logo

FDA Highlights Exemptions for Real World Data-identified AEs

By MedTech Intelligence Staff

On December 20, the FDA updated its Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices web page to remind manufacturers that it has granted several exemptions…

On December 20, the FDA updated its Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices web page to remind manufacturers that it has granted several exemptions…

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Costas Tsougarakis

Laying the Groundwork for an AI Breakthrough

By Costas Tsougarakis

…for AI. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device development and regulation. As part of their…

…for AI. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device development and regulation. As part of their…

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FDA Issues Draft Guidances on Human Factors and VMSR for Medical Devices

The FDA has issued two new draft guidances: Content of Human Factors Information in Medical Device Marketing Submissions and Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The “Content of…

The FDA has issued two new draft guidances: Content of Human Factors Information in Medical Device Marketing Submissions and Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The “Content of…

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European Union Flag

EU MDR: MDCG Proposes Extended Timeline for Legacy Device Compliance

By MedTech Intelligence Staff

…weekly newsletter to stay up to date on the latest news and information on medical device development and regulation. “Where, after having performed this evaluation pursuant to Article 94 MDR,…

…weekly newsletter to stay up to date on the latest news and information on medical device development and regulation. “Where, after having performed this evaluation pursuant to Article 94 MDR,…

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Veranex and Fusion logos

Veranex Acquires Fusion Biotec

By MedTech Intelligence Staff

Global, tech-enabled service provider to the MedTech industry Veranex has acquired Fusion Biotec, a design and engineering firm for complex electro-mechanical diagnostic instrumentation and medical devices located in Orange, California….

Global, tech-enabled service provider to the MedTech industry Veranex has acquired Fusion Biotec, a design and engineering firm for complex electro-mechanical diagnostic instrumentation and medical devices located in Orange, California….

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Ramesh “Sunny” Balwani

Theranos President Sentenced to Nearly 13 Years in Prison

By MedTech Intelligence Staff

Ramesh “Sunny” Balwani, President and Chief Operating Officer of Theranos, was sentenced on Wednesday to 155 months in prison plus three years of probation by U.S. District Judge Edward Davila….

Ramesh “Sunny” Balwani, President and Chief Operating Officer of Theranos, was sentenced on Wednesday to 155 months in prison plus three years of probation by U.S. District Judge Edward Davila….

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