Blog: Medical Devices

Designing Sustainable Medical Devices
04 October 2016

Designing Sustainable Medical Devices

Using IEC 60601-1-9 to Your Advantage More…

Bringing Medical Devices to Market in the U.S.
Field Evaluations for Medical Electrical Equipment
26 July 2016

Field Evaluations for Medical Electrical Equipment

An Overview of the Requirements Under SPE-3000 More…

Not all rubber is made equal!
05 July 2016

Not all rubber is made equal!

A discussion on risk assessments of leachables from medical device components More…

New Finished Product Requirements for EU REACH
Planning Ahead for IEC 60601-1-2 4th Edition for Medical EMC
22 July 2015

Planning Ahead for IEC 60601-1-2 4th Edition for Medical EMC

Market Trends Point to Demand on These Standards Sooner Rather Than Later More…

Top Failures With Mobile Health Apps
27 May 2015

Top Failures With Mobile Health Apps

As the medical device industry looks to enter the world of mobile apps, here are six common issues you should be ready to address. More…

Risky Business: Toxicological Risk Assessments to Support Product Safety
20 January 2015

Risky Business: Toxicological Risk Assessments to Support Product Safety

Extractables, leachables, impurities, degradants, contaminants – what else can go wrong? More…

Making Sense of the RoHS2 Directive for Medical Devices
10 February 2014

Making Sense of the RoHS2 Directive for Medical Devices

Learn more today about non-electrical items and if they are included in the RoHS2 directive. More…

A Closer Look: Medical Devices Used in the Home
03 December 2013

A Closer Look: Medical Devices Used in the Home

What are the challenges the home environment can present when related to medical devices? More…

Ensuring Safety and Essential Performance: Medical Devices Used in the Home
18 November 2013

Ensuring Safety and Essential Performance: Medical Devices Used in the Home

Medical devices used for home healthcare are designed to specifically to ensure safety. More…

What is a Medical Device?
29 May 2013

What is a Medical Device?

The role of medical devices in healthcare is essential; however, defining what constitutes a medical device is not always as clear cut as it may seem. More…

Under the Microscope: The Growth of the Global Medical Device Industry
30 April 2013

Under the Microscope: The Growth of the Global Medical Device Industry

The global medical device industry is growing rapidly and is highly regulated, and expensive to operate within. More…

The Manufacturer's Checklist: The Sale of Medical Devices into the European Union
26 April 2013

The Manufacturer's Checklist: The Sale of Medical Devices into the European Union

In reality, is RoHS 2 truly enforceable and what do manufacturers need to know? Keep reading in today’s expert blog post. More…

What You Should Know: Medical Device Manufacturer's Responsibility and RoHS 2
24 April 2013

What You Should Know: Medical Device Manufacturer's Responsibility and RoHS 2

Did you know RoHS 2 is a CE mark directive? Learn more in today’s blog. More…

A Closer Look at How the European Directive RoHS2 Impacts the Medical Device Industry
22 April 2013

A Closer Look at How the European Directive RoHS2 Impacts the Medical Device Industry

As a manufacturer of electromedical equipment, you have just over a year left to comply with RoHS 2 directive. More…

Essential Performance and Expected Service Life
07 September 2012

Essential Performance and Expected Service Life

Essential Performance and Expected Service Life are two of the most misunderstood requirements in 60601-1, Third Edition standard. Here are some tips to help navigate these two topics. More…