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MedTech Intelligence

Volume 13 Issue No. 09

Building the Next Generation of Wearable Devices to Enhance Remote Patient CarePatient Engagement and Connected Medical Devices:
Building the Next Generation of Wearable Devices
to Enhance Remote Patient Care

By Adrian Pittman, Google; Bernhard Kappe and Randy Horton, Orthogonal

In this series we examine the future of the medical device industry—from manufacturing to the consumer-patient experience.


The Business Value of Cybersecurity in MedTechThe Business Value of Cybersecurity in MedTech

Sponsored By Irdeto

Build a secure line of defense for your devices against a growing range of cyberattacks. Irdeto's report in collaboration with Censuswide has identified clear ways for Health companies to improve customer and patient outcomes, make better data-driven decisions, increase trust, and generate more revenue.

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Featured Articles

Medtronic Recalls HVAD Pump Implant Kits for Product Failure

By MedTech Intelligence Staff

There have been 29 complaints, including 19 serious injuries and two deaths, related to the device issue.

FDA Authorizes New Device that Protects the Brain From Head Hits

By MedTech Intelligence Staff

The Q-Collar uses jugular compression to help protect an athlete’s brain from the effects of repetitive head impacts.

Siemens - Modern and integrated manufacturing execution in medical devices

Virtual Optimism:
Keep Remote Patient Monitoring and Telemedicine in Your Post-Pandemic Care Delivery Mix

By Donna Morrow, Noteworth

As restrictions lift and in-person visits become viable again, the use of virtual care technology — particularly telemedicine and remote patient monitoring (RPM)—is here to stay.


Medical Devices: Is There Life After Death?

By Melanie J. Haga, Back Thru The Future

Regardless of the reason for disposing of a medical device or other electronic equipment, the product must be destroyed in a manner in which it can never be reused or identified as coming from your organization. In addition, the resulting materials from the destruction process be disposed of in an environmentally appropriate and regulatory compliant manner.


EU IVDR - Process, Data, Reporting & PlanningEU IVDR - Process, Data, Reporting & Planning

March 30 - April 27, 2021

The European In Vitro Diagnostic Regulation (EU IVDR) will profoundly affect the global diagnostics market, requiring new procedures, evidence development, documentation, organizational structures, data management, reporting, and a reassessment of legacy portfolios. Preparation will involve strategic thinking and buy-in at the highest levels.

Implementation of IVDR is scheduled for May 2022, with no indication that it will be deferred. For those who have not already begun planning for the change, it is urgent to begin now or face exclusion from the European market.

March 30, 2021: EU IVDR Introduction

April 6, 2021: Quality Processes and Documentation

April 13, 2021: Clinical Evidence & Surveillance

April 20, 2021: Supply Chain Management: Economic Operators, UDI, and Labeling

April 27, 2021: Strategy and Planning

Details & Registration

MedTech Library

MDR Documentation Submissions: Best Practices GuidelinesMDR Documentation Submissions: Best Practices Guidelines

Sponsored By bsi.

The two most frequent reasons for delays to technical documentation reviews are:

  • BSI has not been provided with all of the information needed for the review
  • The information is present within the technical documentation, but is difficult to locate

To reduce the frequency of the above issues, BSI Medical Devices Group proposes this guidance, informally known as “MDR Documentation Submissions: Best Practices Guideline."

Download now!

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