Featured Articles
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20 Years Later, 21 CFR Part 11 Is More Relevant Than Ever
3/11/2022
With the evolution of technology, 21 CFR Part 11 is more applicable than ever due to the increased use of digital technology for these quality management tasks.
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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.
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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.
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3 Reasons Life Sciences Should Adopt A Data-Centric Quality Mindset
2/16/2022
So few are poised to adopt a data-centric approach by using digitization, analytics, and AI that those who do will reap benefits from the data in their now unstructured documents.
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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.
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Modern Manufacturing: The Investment in Digitization Costs Less Than Falling Behind
2/1/2022
By adopting digital solutions today, manufacturers can capitalize on the opportunities of modern manufacturing solutions and realize their full potential.
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Three Tips On How To Select A Contract Manufacturing Organization
1/31/2022
Learn how to identify and choose a CMO that has a modern manufacturing solution, offer transparency throughout the entire production cycle, and can scale quickly.
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How Effective Training Management Can Help You Prevent Quality Issues
1/28/2022
Training defines the quality of the single most important asset of your organization: your employees. A good training management process serves as a preventative measure against poor quality.
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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.
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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.