Featured Articles

  1. What You Need To Know About ISO 13485 And 21 CFR Part 820 6/10/2022

    Here we answer some of the questions commonly asked by companies striving for compliance with ISO 13485 requirements.

  2. Medical Device Industry Guide To Selecting QMS Software 3/22/2022

    If your company is looking to purchase or develop medical device QMS software, you can’t afford to overlook these 10 most important system capabilities.

  3. FDA Details Post-COVID Transition Guidelines For EUA Devices 3/9/2022

    Review the EUA transition guidances in more detail and learn how medical device manufacturers and other stakeholders can prepare for an orderly and transparent transition to normal regulated operations.

  4. Vision And Paperless Ops Make Northeast Scientific A MedTech Industry Leader 2/28/2022

    Managing all the documentation for the many devices Northeast Scientific remanufactured was complex and prone to errors. A modern manufacturing execution system allowed them to manage documentation by eliminating paper.

  5. 4 Ways To Prepare For UK Medical Device Regulations 2/11/2022

    Medical device companies that are working with inefficient or inaccessible systems can take these actions right now to positively affect their medical device regulatory strategy.

  6. Medical Device Supply Chain Backup 1/27/2022

    It’s impractical to think that the medical device supply chain can be completely domestic, but there are steps that can be taken to deal with fluctuating COVID-19 protocols and transportation problems.

  7. Small Regulatory Steps For AI In SaMD 12/28/2021

    Recently released guiding principles for good machine learning practice in medical devices and other regulatory documents, are giving medical device companies an indication of what regulations might look like.

  8. Medtech Manufacturing: From Disruption To Evolution 12/16/2021

    Medical device manufacturing is a complex industry, so figuring out what areas to digitize can be difficult and different for every company. Here we explore different ways medical device and diagnostic manufacturers are embracing digital tools to maximize the value of ever-increasing data, as the industry pivots from crisis mode to evolution.

  9. Simplifying Commercial Software Validation In Medtech Manufacturing 11/21/2021

    Commercial off-the-shelf (COTS) software has dramatically enhanced medical device manufacturers’ ability to accelerate production, integrate processes, and manage quality effectively. Learn more about FDA guidelines on the horizon for COTS software and tips on how to approach validation until such guidelines are finalized.

  10. How Electronic Batch Records And Device History Records Close The Digital Manufacturing Gap 11/21/2021

    We need to remedy the fact that the vast majority of life science manufacturers are still on paper. Digitizing the paper-based production record process can close this gap by creating productive connections between people, processes, and systems throughout the manufacturing process and across the entire enterprise for a holistic view of production data.