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

23 Mar 2021
New Standard for Vaccine Storage Units

Electrical Safety and Performance Considerations

27 Nov 2020
Market drivers for electronics in a COVID-19 world

Considerations and innovations in hygiene, health & safety

17 Nov 2020
Mask Assessments 101

A Guide to Requirements for Face Coverings

16 Jun 2020
Pharmaceutical stability contingency and disaster recovery

Mitigating the risks in pharmaceutical stability storage

03 Mar 2020
Why Did My Part Break?

A Look at the Failure Analysis and Investigation Process

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

20 Nov 2018
The Keys to Success

Outsourcing Stability Studies to Contract Laboratories

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.

26 Dec 2011
A Year in Review
12 Dec 2011
A Closer Look: RoHS 2