Blog

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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IEC 62304 Software Development Life Cycle

Avoid Common Medical Device Software Development Life Cycle Pitfalls

Learn Potential Software Development Life Cycle Pitfalls to Pay Attention To IEC 62304 is the international standard that defines software development life cycle requirements for medical device software. IEC 62304 was developed from the perspective that product testing alone is insufficient to ensure patient safety. It provides a common framework for medical device manufacturers to develop...
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Don’t Forget Safety Testing and the Value of Risk Management!

Establish the Safety of Your Medical Device with IEC 60601 Compliance In our experience, the most frequently forgotten aspect of medical device development and commercialization from emerging companies is establishing a safety profile of a product. While clinical data or clinical trials may be necessary for establishing safety for some products, many Class II devices...
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