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Localizing Medical Device Content for Global Markets

Oct 28, 2021

Medtech's Biggest Problem Right Now: Hospital Labor Shortages

Oct 27, 2021

A Strong Q3 Is Helping Masimo Step into 2022 with Swagger

Oct 27, 2021

The Magnetic Force in Medicine: Integrating Magnets Safely into Medical Devices

Oct 27, 2021

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The World of Quality Control Has Changed for Medical Device Manufacturers

Oct 27, 2021

Is Accuray Changing Its Tone to Become More Competitive?

Oct 26, 2021

FDA Advisory Panel Red Lights Integra's Breast Reconstruction Mesh

Oct 26, 2021

Guardant Makes Big Splash at ACG with Lunar-2 Data

Oct 26, 2021

U.S. Medtech Incubators and Accelerators

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

Highlights

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 product’s...

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...

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...

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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.

6 Questions to Ask Yourself about ISO 11607 Compliance

Aug 24, 2018

These FDA-consensus standards guide packaging design and validation—how compliant are you, and how ready are you for the upcoming revision?

How Clean is Clean Enough?

Jun 22, 2018

Here are some takeaways from ISO 19227 for orthopedic implants.

The Countdown to Implementing ISO 13485:2016

Jan 31, 2018

There's one year to go before implementing ISO 13485:2016 becomes a requirement. Have you started yet?

Complying with ISO 13485:2016's New Expectations for Supplier Management

Dec 18, 2017

Changes to ISO 13485 are impacting supplier management. Are you prepared?

New Global Compliance Requirements Will Impact Medical Device Industry

Nov 08, 2017

Modern technologies can help prepare medical device and diagnostics companies for change.

Hospital Disinfectants: Why You Should Reconsider Your Materials Testing Approach

Jul 05, 2017

Materials provider has developed a testing protocol for evaluating the effects of disinfectants on plastics. ...

ISO 11607: New Standard Clears Up Packaging Confusion

Aug 01, 2006

The two-part standard harmonizes the requirements of ISO 11607:2000 and EN 868-1 into one global standard.

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