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ISO 14971:2019, FMEA, and Risk Management

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...

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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.

Medical Packaging Validation: Complying with the Quality System Regulation and ISO 11607

Aug 01, 1997

By identifying the optimum time frame for each key process variable, validation achieves process control and ensures that package requirements are met.

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