Swiss National Council Votes To Accept FDA Approved Medical Devices

By MedTech Intelligence Staff

In addition to challenges brought by new EU MDR, Switzerland has struggled to approve and introduce new devices due to its revised national medical device ordinance, which created even tougher import hurdles.

Bridging Communication Gaps

By MedTech Intelligence Staff

Providing the right tools and processes can help improve communication between design, engineering and procurement as companies continue to face supply chain challenges and workforce shortages.

WHO Convenes Panel to Identify Priority Pathogens for
Research and Oversight

By Laís Junqueira, Elsevier

More than 300 scientists will consider the evidence on over 25 virus families and bacteria—as well as “Disease X” (an unknown pathogen that could cause a serious international epidemic)—and recommend a list of priority pathogens that need further research and investment.

Moving Beyond ASL with Design Controls and Supplier Management

Sponsored By ComplianceQuest

Design controls and supplier information are vital components to building your product’s digital thread. Learn how to add value to your device by keeping track of supplier and manufacturing controls through design, and how to build practical data structures to provide the visibility needed so your suppliers and manufactures can build high-quality products that your customers will swear by. Presenter: Tim Brown, VP of Products – PLM, ComplianceQuest.

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Baxter Recalls WatchCare IMS Due to Risk of Interference with
Nearby Medical Equipment

By MedTech Intelligence Staff

Baxter Hillrom is recalling its WatchCare Incontinence Management System (IMS) following reports that the radiofrequency emissions (RF) from WatchCare devices may interfere with other medical devices.

Preparing for a Data-first Regulatory World

By Renato Rjavec, Amplexor

As data, rather than document-based dossiers, become the focus for regulatory processes, regulatory affairs managers need to consider whether team skill sets need to be refreshed to reflect new ways of working.

Featured Quote

While intentional misconduct is a rare occurrence in scientific publishing and very difficult to determine, unintentionally including altered or duplicate images is a common phenomenon that can fundamentally damage all parties involved and damage scientific research, in general.

— Dror Kolodkin-Gal, Ph.D. - Proofig

Predictive Quality for Medical Devices

Sponsored By Critical Manufacturing

Wouldn’t it be great to know and be able to automatically release products when every process stayed within the specified envelope? And to sample or test only as much as a particular process requires, no more or less? Those are the promises of predictive quality. Get to know what executives from Medtronic, B Braun, Jabil and Ultradent have to say about it.

The Post-Market Gambit: After EU MDR and IVDR:
A Systematic Compliance Framework for Driving MedTech Innovation

Sponsored By Huma.AI

Based on extensive research and expert interviews, this 60-page ebook explores the challenges, costs, and opportunities that EU MDR and IVDR have created. Moreover, it offers a solution and vision for a New Era of Post-Market Intelligence.

Increase agility and innovation with PLM for medical devices

Sponsored By Siemens

With medical devices becoming more complex and regulatory oversight becoming stricter, it is difficult for manufacturers to deliver products effectively and maintain a competitive edge. However, there are always ways to improve innovation, speed to market and data quality while continuing to be compliant.