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MedTech Intelligence

Volume 13 Issue No. 08

Joe Muldoon, FAST BioMedicalMedTech Predictions for 2021

By Joe Muldoon, FAST BioMedical

We have the opportunity to refine processes that were implemented in a hurry during the pandemic, along with the insight to improve the entire healthcare system.

bsi. Explaining IVD Classification Issues

Featured Articles

Rice University Gets Up to $1 Million to Develop Sensor that Detects Airborne COVID-19

By MedTech Intelligence Staff

The real-time bioaerosol sampling system can detect a very low concentration of SARS-CoV-2 in the air.

President Biden Nominates Chiquita Brooks-LaSure
to CMS Administrator

By MedTech Intelligence Staff

Brooks-LaSure has more than two decades of experience in health policy and played a crucial part in the passage of the Affordable Care Act.


DNV GLISO 13485 Medical Devices QMS Foundation training

This 1-day #LiveOnline #training #course clarifies #ISO13485:2016 requirements and interpretations. Organizations that need to show evidence that they can provide medical devices, which consistently meet customer and regulatory requirements, will benefit from understanding ISO 13485. A must for those, who will be auditing their own organizations.

Learn more and register


Avoiding FDA Enforcement Actions: Understanding Quality Systems

By Amy Scanlin, EAS Consulting Group, LLC

The greatest challenge faced is an understanding of the intent of the written regulations and applying them correctly.


Future of Specialty Telemedicine

By Jonathan Wiesen, M.D., MediOrbus

Its success lies in a synergy between the technological and the clinical.

More Cyberattacks in Healthcare, Yet Most MedTech Leaders Unprepared, Says Survey

By MedTech Intelligence Staff

A mere 13% of IoMT leaders believe their organization is in a good place to mitigate future risks related to cybersecurity.


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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