Intertek Blog: Medical Devices
18 Feb 2025
Streamlining Global Market Access for Medical Devices with the CB Scheme
Understanding the CB Scheme and Its Benefits for Medical Device Manufacturers
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Navigating the FDA's New Draft Guidance on Chemical Analysis for Medical Devices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
04 Feb 2025
Emerging Sustainability Standards Are Redefining Medical Imaging Systems
What Medical Device Manufacturers need to know about Meeting the Challenges of New ENERGY STAR® Standards.
16 Jan 2025
The Importance of Ingress Protection Testing for Medical Devices
One of the most crucial types of testing for medical devices is Ingress Protection (IP) testing. IP testing evaluates a device’s resistance to dust, water, and other environmental factors.
26 Nov 2024
Understanding the 21 CFR 820 Amendment
A Major Shift Toward Global Harmonization in Medical Device Quality Management
19 Nov 2024
Navigating the New Era of Medical Device Regulation
Understanding the Challenges and Opportunities of Transitioning to the European Union's Rigorous MDR Framework
13 Nov 2024
Revolutionizing Healthcare for an Aging Population
Highlights from the 2024 MedTech Conference on the Future of Home Healthcare
05 Nov 2024
Essential Performance in Medical Devices: A Critical Component of Patient Safety
Understanding the Role of Essential Performance in Ensuring Effective and Safe Medical Devices
21 Oct 2024
Defining a Medical Device: Understanding Key Distinctions from Laboratory Equipment
Navigating the Regulatory Landscape to Ensure Compliance and Patient Safety
17 Sep 2024
Understanding Photobiological Compliance Requirements for Medical Devices
Navigating the Complexities of Light-Based Medical Device Standards to Ensure Safety and Compliance in a Growing Market
10 Sep 2024
Optimising Healthcare Supply Chain Auditing
How Shared Audits Save Time, Energy and Resources
24 Jul 2024
Navigating China's NMPA Program for Medical Device Manufacturers
Essential Steps and Insights for Successful Market Entry into China
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
24 Apr 2024
Understanding the 510(k) Submission Process
Frequently asked questions from medical device manufacturers
16 Apr 2024
The Future of Healthcare – The Evolution of AI and ML in Medical Devices
Improving patient outcomes while ensuring privacy, security, and regulatory compliance
14 Dec 2023
Software in a Medical Device vs. Software as a Medical Device: Understanding the Differences - Part 2
Medical Software Development
12 Dec 2023
Software in a Medical Device vs. Software as a Medical Device: Understanding the Differences - Part 1
A look at the convergence of hardware-centric medical devices and software-driven solutions
24 Oct 2023
The Secret to Success for Medical Device Manufacturers
Working Effectively with Testing and Certification Agencies
10 Oct 2023
Trends in Global Medical Device Design and Development
Discover how regulatory requirements, patient access, usability, cybersecurity, sustainability and more are transforming the medical industry
09 May 2023
Medical Device Compliance for Home Healthcare Settings
Considerations for designing and manufacturing electronic medical devices
13 Sep 2022
Driving compliance and transparency in pharma supply chains
Why the alignment of audit scope with the correct industry standard is important
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
27 Nov 2020
Market drivers for electronics in a COVID-19 world
Considerations and innovations in hygiene, health & safety
16 Jun 2020
Pharmaceutical stability contingency and disaster recovery
Mitigating the risks in pharmaceutical stability storage
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
29 Jan 2019
Biomarker Discovery, Technical Qualification and Validation
Using LBA, LC-MS and HRAMS Assay Formats
30 Oct 2018
Bioanalysis and Immunogenicity Series - Volume 4
Biosimilar Pharmacokinetic and Immunogenicity Method Development and Validation
25 Sep 2018
Bioanalysis and Immunogenicity Series - Volume 3
Technologies for Measurement: A Case Study
04 Sep 2018
Bioanalysis and Immunogenicity Series - Volume 2
Using Innovative and Non-Conventional Techniques to Address Bioanalytical Challenges
07 Aug 2018
Bioanalysis and Immunogenicity Series - Volume 1
FDA Expectations Regarding Immunogenicity Testing
06 Mar 2018
Fuel Cell Technologies - An External Supply of Chemical Energy
Generating Electricity from an Electrochemical Reaction
06 Dec 2016
Mitigating Risks in Pharmaceutical Stability Storage
Stability studies represent considerable investment in cost and time. What steps can be taken to mitigate the risks of losing valuable samples in storage due to unforeseen disasters?
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
26 Apr 2016
Ensuring Safe and Stable Inhaled Medicines
Stability studies play an important role in inhalation drug development
14 Mar 2016
Establishing Health-Based Exposure Limits for Active Pharmaceutical Ingredients
Are your manufacturing standards in line with the new EMA guideline?
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
02 Jun 2015
Betting the Pharm: Determining Regulatory Expectations for Pharmacology Studies
Are you generating sufficient pharmacology data and presenting the data effectively for your preclinical drug development program?
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.
08 Jan 2014
Update: RoHS 2 Deadline for July 22, 2014
When is RoHS 2 compliance required for declaration of CE Mark?
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.