Category: Medical Devices

The NEW ISO 13485:2016 – Procrastination Can Cost You

ISO 13485 is the international standard medical device companies follow to demonstrate their ability to consistently meet both customer and regulatory requirements with their devices and related services. Regulators worldwide, including the EU, Canada, Australia and Japan, have integrated ISO 13485 into their regulatory requirements. The standard is designed to be used by organizations throughout...
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Improving FDA Reviews of Combination Products

Just a few short weeks ago, Robert Califf, the US Food and Drug Administration (FDA) Commissioner nominee, endorsed an internal report that provided recommendations on how the FDA could improve reviews of combination products. Combination products include: Products comprised of two or more regulated components, such as drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically,...
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Life Science Webinar

Is Your Medical Device a Secret Safety Risk?

WHEN: Thursday February 26th WHERE: Your office TIME: 1.30pm – 3.00pm REGISTER HERE Compliance with IEC 62304 is required for all electromedical devices where basic safety is dependent on software or firmware. But many device companies remain unaware that the devices they manufacture must meet this standard. That may be because there’s confusion stemming from a key...
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How to Structure a Medical Device Company

How to Structure a New Medical Device Business

There’s More to Being a Medical Device Business than IP and R&D An emerging medical device business tends to focus their energy on product development and R&D. This is understandable because medical device founders are often first experienced innovators. As innovators, there’s a natural affinity to maintain a continued focus on product development and maturation....
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