Standards

BROUGHT TO YOU BY

Recent

Liability Issues Continue to Evolve in Computer-Assisted Surgery

Jul 02, 2020

How Will the COVID-19 Pandemic Impact Medtech Careers?

Jul 02, 2020

FDA Clears Spinal Elements’s Anterior Cervical Fixation System

Jul 02, 2020

BeAT-HF: A Turning Point in Heart Failure Therapy

Jul 02, 2020

News
Products
Whitepapers

EU Medical Device Regulation: What Should You Do During the Delay?

Jul 01, 2020

Straight Out of Stealth Mode: Protaryx Raises $8M

Jul 01, 2020

Ancora’s IDE for CorCinch-HF Pivotal Study Greenlit by FDA

Jun 30, 2020

New Titanium Foam Spinal Implant Comes Pre-Attached to Disposable Delivery Device

Jun 30, 2020

Webinar: How the Medtech Industry Can Respond to Crisis

Listen on-demand to our series of free webinars examining the COVID-19 pandemic response and providing tips to help medtech companies prepare for future emergencies.

Highlights

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...

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...

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...

About
Advertise
Subscribe
Design News
PlasticsToday
Packaging Digest
Powder & Bulk Solids

MD&M West
MD&M East
MD&M Minneapolis
BIOMEDevice Boston
BIOMEDevice San Jose
Sitemap

Accessibility
Privacy Policy
Cookie Policy
Terms of Use
Visitor Terms and Conditions