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04 Jun 2024

Ensuring Cybersecurity in Medical Devices

A Proactive Approach can Streamline Compliance and Reduce Vulnerabilities

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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

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24 Apr 2024

Understanding the 510(k) Submission Process

Frequently asked questions from medical device manufacturers

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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

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

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09 May 2023

Medical Device Compliance for Home Healthcare Settings

Considerations for designing and manufacturing electronic medical devices

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13 Sep 2022

Driving compliance and transparency in pharma supply chains

Why the alignment of audit scope with the correct industry standard is important

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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

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23 Nov 2021

Navigating Cybersecurity Standards and Regulations for Medical Devices

Keeping patient information and networks secure

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07 Sep 2021

Reflecting on Remote Supplier Audits

Helping the pharma industry maintain focus on quality

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24 Aug 2021

On Target with the Right Information at the Right Time

Demystifying a Custom Test Program

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08 Jun 2021

Success through Failure with Accelerated Stress Testing

Breaking Your Product Can be Good for Design

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06 Apr 2021

Medical EMC Updates

Changes under IEC 60601-1-2 4th Edition, Amendment 1

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23 Mar 2021

New Standard for Vaccine Storage Units

Electrical Safety and Performance Considerations

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09 Feb 2021

Ensuring the Safety and Performance of Electrical Products

The Testing and Certification Process in North America

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27 Nov 2020

Market drivers for electronics in a COVID-19 world

Considerations and innovations in hygiene, health & safety

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17 Nov 2020

Mask Assessments 101

A Guide to Requirements for Face Coverings

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04 Aug 2020

Medical Device Compliance

IEC 60601-1-3 2nd Amendment

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14 Jul 2020

Vibration Testing: Fixtures

Get It Right the First Time

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07 Jul 2020

Vibration Testing Insights

What You Need to Know To Pull Off a Vibration Test

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16 Jun 2020

Pharmaceutical stability contingency and disaster recovery

Mitigating the risks in pharmaceutical stability storage

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29 May 2020

Connectivity in Medical Devices

Cybersecurity and Risk Management Principles

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03 Mar 2020

Why Did My Part Break?

A Look at the Failure Analysis and Investigation Process

14 Jan 2020

Testing and Certification in North America

A Look at OSHA's NRTL Program

26 Nov 2019

The Bridge to China

Medical Device Approvals with the National Medical Products Administration (NMPA)

19 Jul 2019

Medical Device Cybersecurity - Part 2

Safely Test and Deploy Connected Products

16 Jul 2019

Medical Device Cybersecurity - Part 1

Safely Test and Deploy Connected Products

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

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

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06 Mar 2018

Fuel Cell Technologies - An External Supply of Chemical Energy

Generating Electricity from an Electrochemical Reaction

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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?

04 Oct 2016

Designing Sustainable Medical Devices

Using IEC 60601-1-9 to Your Advantage

27 Sep 2016

Bringing Medical Devices to Market in the U.S.

Five Steps to Commercialization

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

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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.

26 Dec 2011

A Year in Review

12 Dec 2011

A Closer Look: RoHS 2