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Another Medtech SPAC Fades to Black

Oct 04, 2023

Phillips-Medisize, GlucoModicum Partner on Needle-Free CGM

Oct 04, 2023

Microsure Nabs €38M Series B2 Funding for Microsurgical Robot

Oct 04, 2023

UK to Invest £30M in Medtech for NHS

Oct 03, 2023

Consider More Than Just User Needs During Medtech Development

Oct 03, 2023

Freudenberg Medical Opens Expanded Manufacturing Facility in Ireland

Oct 03, 2023

What are the 4 Essential Elements of Medical Device Design?

Oct 03, 2023

Removing the Pain from 'Just a Little Pinch' Gynecological Procedures

Oct 02, 2023

U.S. Medtech Incubators and Accelerators

Check out these U.S. medtech incubators and accelerators organized by state.

Highlights

Diving into FDA’s QMSR Alignment with ISO 13485

Sep 08, 2023

Matt Lowe, Chief Strategy Officer for MasterControl, answers the most pressing questions about FDA’s harmonization with the ISO 13485...

Tegra Medical Achieves ISO 14001 Certification

May 01, 2023

The certification is granted to companies that identify and manage business areas to reduce environmental impact.

MedCon 2023 Session Highlights MDUFA V, TAP Pilot, EU MDR

Apr 27, 2023

CDRH director Jeff Shuren discussed updates to the TAP pilot, his top tips for MDR transition, and CDRH’s...

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Nelson Labs Obtains New Accreditation from FDA

Apr 14, 2023

Nelson Labs said the ASCA accreditation should help to accelerate the speed to market for safe, quality devices.

This Company’s False Compliance with CISPR 11 Resulted in a $12 Million FCA Fine

Mar 06, 2023

Take it from Advanced Bionics. If you’re going to use CISPR 11 to support findings in pre-market applications, it better be correct.

Risk Management Considerations for IoMT & Medtech Product Design

Apr 15, 2022

IoMT products require effective risk management and a quality management system, among other important aspects.

The Future of Gamma Irradiation for Medical Device Sterilization

Nov 24, 2021

Gamma irradiation is critical in ensuring the healthcare industry can meet the global demand for sterile medical devices.

Benefits of ISO 13485 Certification for Medical Device Manufacturing

Aug 09, 2021

ISO 13485 certification is an internationally recognized standard for medical device companies involved at any stage of a...

Risk Management—What’s Failure Analysis Got to Do With It?

Jul 09, 2021

A webinar from PAXXUS will explore the relationship between medical device packaging failure analysis and risk management.

The New and Improved ISO 10993-12:2021—What Is Really Changing

Jun 02, 2021

While the updated standard features no major revisions, there is more discussion on what to consider for sample preparation.

Complying with ISO 14971:2019

Aug 07, 2020

Separate risk management and FMEA for better medical device development.

A Few New Challenges with EU MDR

Mar 05, 2020

Experts speaking at MD&M West offered strategies for preparing for the European Union's Medical Device Regulation.

Key Medical Packaging Standard, ISO 11607-1/2 Published; More Regulatory Support on the Way

Mar 15, 2019

With the EU Medical Device Regulations just over one year away, this latest revision aims to help medical device manufacturers meet the regulation’s General Safety and Performance Requirements.

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