Intertek Blog: Medical Devices
14 Dec 2023
Software in a Medical Device vs. Software as a Medical Device: Understanding the Differences - Part 2
Medical Software Development
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
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
13 Sep 2022
Driving compliance and transparency in pharma supply chains
Why the alignment of audit scope with the correct industry standard is important
31 Aug 2021
Reflecting on Remote Supplier Audits
Helping the pharma industry maintain focus on quality
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)
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?
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?
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?
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.