Pro Tips Surrounding Design Controls for Medical Devices

    Breaking Down Design Control Requirements for Medical Device Development Teams
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    A Simple Breakdown of ISO and IEC Standards for SaMD

    Understanding the difference and benefits between ISO and IEC Standards for Software as a Medical Device
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    What are CAPAs?

    Learn the purpose of Corrective and Preventive Actions (CAPAs) for Medical Device Development.
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    5 Steps to Obtain a CE Marking on Your Medical Device

    How to utilize ISO 13485 to acquire a CE Marking on your Medical Device.
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    What is ISO 13485:2016?

    An easily digestible overview of ISO 13485 and how it applies to your medical device company.
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    ISO 13485 - Regulatory Requirements on Medical Devices

    How embracing regulations can give you a leg up on your competition.
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    ISO 13485 vs. CFR Part 820

    A comparative study on the key differences between FDA’s QSR and ISO’s QMS.
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