Blog: Medical Devices
The Secret to Success for Medical Device Manufacturers
Working Effectively with Testing and Certification Agencies More…
Trends in Global Medical Device Design and Development
Discover how regulatory requirements, patient access, usability, cybersecurity, sustainability and more are transforming the medical industry More…
Borderline Cosmetics in the EU
Understanding a product's classification for regulatory compliance More…
Medical Device Compliance for Home Healthcare Settings
Considerations for designing and manufacturing electronic medical devices More…
FDA Guidance for Medical Device Cybersecurity: What Manufacturers Need to Know
The importance of identifying vulnerabilities and controlling risk to demonstrate product safety and effectiveness More…
Navigating Cybersecurity Standards and Regulations for Medical Devices
Keeping patient information and networks secure More…
On Target with the Right Information at the Right Time
Demystifying a Custom Test Program More…
Success through Failure with Accelerated Stress Testing
Breaking Your Product Can be Good for Design More…
Medical EMC Updates
Changes under IEC 60601-1-2 4th Edition, Amendment 1 More…
Ensuring the Safety and Performance of Electrical Products
The Testing and Certification Process in North America More…
Measurement of Residual Stress Using X-Ray Diffraction (XRD)
What is Residual Stress and How can Intertek Help You? More…
Medical Device Compliance
IEC 60601-1-3 2nd Amendment More…
Vibration Testing: Fixtures
Get It Right the First Time More…
Vibration Testing Insights
What You Need to Know To Pull Off a Vibration Test More…
Connectivity in Medical Devices
Cybersecurity and Risk Management Principles More…
Why Did My Part Break?
A Look at the Failure Analysis and Investigation Process More…
Testing and Certification in North America
A Look at OSHA's NRTL Program More…
The Bridge to China
Medical Device Approvals with the National Medical Products Administration (NMPA) More…
Medical Device Cybersecurity - Part 2
Safely Test and Deploy Connected Products More…
Medical Device Cybersecurity - Part 1
Safely Test and Deploy Connected Products More…
EMC & Wireless Compliance for Active Implantable Medical Devices
Ensuring Safety and Performance in a Connected World More…
Medical Robots and Robotic Devices
Ensuring Compliance with Regulatory Requirements and New Standards More…
Preparing for ROHS 2019 Compliance (Part 1 - Sourcing)
Changes to Restriction of Hazardous Substances (RoHS) Effective 22 July 2019 More…
Identification and Quantification of Volatile Organic Compounds in Food Contact Materials
Ensuring the safety of polymers used in food contact materials More…
Fuel Cell Technologies - An External Supply of Chemical Energy
Generating Electricity from an Electrochemical Reaction More…
Designing Sustainable Medical Devices
Using IEC 60601-1-9 to Your Advantage More…
Bringing Medical Devices to Market in the U.S.
Five Steps to Commercialization More…
Field Evaluations for Medical Electrical Equipment
An Overview of the Requirements Under SPE-3000 More…
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
See what the new ruling means by checking out our infographic More…
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
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
Extractables, leachables, impurities, degradants, contaminants – what else can go wrong? More…
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
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
Medical devices used for home healthcare are designed to specifically to ensure safety. More…
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
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
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
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
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
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…