Intertek Blog: Medical and Pharmaceutical
24 Mar 2025
Extractables and Leachables Examples
Strategies for Overcoming Challenges in Pharmaceutical Packaging Evaluation
11 Feb 2025
Pharma supply chain management: questions to ask an audit partner - Part 2
Future proofing your organisation’s focus on quality
28 Jan 2025
Pharma supply chain management: questions to ask an audit partner - Part 1
Focus on audit methodology and skills
24 Jan 2025
Navigating the FDA's New Draft Guidance on Chemical Analysis for Medical Devices
What You Need to Know
10 Sep 2024
Optimising Healthcare Supply Chain Auditing
How Shared Audits Save Time, Energy and Resources
04 Jun 2024
Ensuring Cybersecurity in Medical Devices
A Proactive Approach can Streamline Compliance and Reduce Vulnerabilities
28 May 2024
Understanding PFAS Regulations and Their Impact on Medical Devices
The Role of PFAS in Medical Devices and the Implications for Industry Compliance
19 Jul 2022
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
23 Nov 2021
Navigating Cybersecurity Standards and Regulations for Medical Devices
Keeping patient information and networks secure
07 Sep 2021
Reflecting on Remote Supplier Audits
Helping the pharma industry maintain focus on quality
24 Aug 2021
On Target with the Right Information at the Right Time
Demystifying a Custom Test Program
08 Jun 2021
Success through Failure with Accelerated Stress Testing
Breaking Your Product Can be Good for Design
09 Feb 2021
Ensuring the Safety and Performance of Electrical Products
The Testing and Certification Process in North America
05 Jan 2021
Measurement of Residual Stress Using X-Ray Diffraction (XRD)
What is Residual Stress and How can Intertek Help You?
26 Nov 2019
The Bridge to China
Medical Device Approvals with the National Medical Products Administration (NMPA)
02 Jul 2019
EMC & Wireless Compliance for Active Implantable Medical Devices
Ensuring Safety and Performance in a Connected World
18 Jun 2019
Medical Robots and Robotic Devices
Ensuring Compliance with Regulatory Requirements and New Standards
18 Dec 2018
Preparing for ROHS 2019 Compliance (Part 1 - Sourcing)
Changes to Restriction of Hazardous Substances (RoHS) Effective 22 July 2019
10 Apr 2018
Identification and Quantification of Volatile Organic Compounds in Food Contact Materials
Ensuring the safety of polymers used in food contact materials
06 Mar 2018
Fuel Cell Technologies - An External Supply of Chemical Energy
Generating Electricity from an Electrochemical Reaction
26 Jul 2016
Field Evaluations for Medical Electrical Equipment
An Overview of the Requirements Under SPE-3000
05 Jul 2016
Not all rubber is made equal!
A discussion on risk assessments of leachables from medical device components
22 Jul 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
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.
20 Jan 2015
Risky Business: Toxicological Risk Assessments to Support Product Safety
Extractables, leachables, impurities, degradants, contaminants – what else can go wrong?
10 Feb 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.
03 Dec 2013
A Closer Look: Medical Devices Used in the Home
What are the challenges the home environment can present when related to medical devices?
18 Nov 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.
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.
26 Apr 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.
24 Apr 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.
22 Apr 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.