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MedTech Intelligence

Volume 13 Issue No. 07

FDAIn 2020, FDA Authorized 132 Novel Medical Devices

By MedTech Intelligence Staff

The record-high number of authorizations last year was a significant jump over 2019.

bsi. Explaining IVD Classification Issues

Featured Articles


How Hospitals and Health Systems Can Accelerate Innovation

By Kristian A. Werling, McDermott Will & Emery

Among the many lessons from the COVID-19 pandemic, it’s clear that the future of healthcare belongs to those who can harness science and technology—sometimes rapidly—to improve population health through more efficient and accessible care.

Innovations in Self-Monitoring Blood Glucose Devices Will Impact Healthcare Services

By Sunil Jha, Global Market Insights

Seamless and personalized diabetes care has become a new normal.


How Life Sciences Companies Can Level Up Healthcare Education in Post-COVID Era

By Parth Khanna, ACTO

It’s time for these companies to bridge the knowledge gap and transform how healthcare information is accessed and used.


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

COVID-19 Introduces New Risks, Hazards in Health Tech

By MedTech Intelligence Staff

With the accelerated adoption of many new technologies, ECRI’s annual health technology hazards list has been transformed by the COVID-19 pandemic.

CAPA Corner

Why You Must Have a Single Source of Truth for CAPA

By Jon Speer, Greenlight Guru

CAPA consistently remains a top reason for FDA’s 483 observations, usually due to inadequate processes or inconsistent adherence to regulatory requirements.


The New Way of Healthcare with Additive Manufacturing

By Christopher Cho, nTopology

Disruptions in the traditional manufacturing supply chains made the world realize the benefits of additive manufacturing. In this article, we will focus on the development of this practice and the diverse ways it has been applied in the medical industry—from COVID-19 swabs to orthopedic implants.

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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