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366 results:

Avoid the Five Most Common Mistakes When Submitting a Premarket Notification (510(k))

How you can avoid the most common errors made when submitting a 510(k), the “premarket notification,” with simple measures

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Combination products: Applicable law and regulatory requirements

Combination products: Applicable law and regulatory requirements (EU law) Combination products consist of the combination of a medical device and a medicinal product. Since both medical device and

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Six steps to market authorization for medical devices in Germany and the EU

In 7 steps to a medical device Anytime you want to launch a medical device on the market, you quickly come to the question of which legal regulations you have to comply with. This article will gi

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IEC 81001-5-1: The standard for secure health software

IEC 81001-5-1: The standard for secure health software The cybersecurity standard IEC 81001-5-1 focuses on how IT security needs to be taken into account in the software life cycle. As a special

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The Machinery Directive: Which Parts Apply to Medical Devices?

The Machinery Directive: Which Parts Apply to Medical Devices? The Machinery Directive (2006/42/EC) is generally applicable to machines of all types. However, the directive can also be relevant for

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Market Access US & International

Would you like to bring your medical products to market worldwide (in Europe, the USA, China, etc.) quickly, safely and at minimal cost? Then we, the Johner Institute, are your partner! Regulatory

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Post-Market Clinical Follow-up: Best Practices for PMCF

Post-Market Clinical Follow-up: Best Practices for PMCF How to meet PMCF regulatory requirements as quickly as possible Post-market clinical follow-up is increasingly being criticized by the n

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Companion Diagnostics (CDx) – Strictly Monitored In Vitro Diagnostic Devices

Companion Diagnostics (CDx) – Strictly Monitored In Vitro Diagnostic Devices Companion diagnostics (also known as CDx) are used together with a medicinal product. Physicians use them, for example,

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Laboratory Products for “Research Use Only” (RUO) – Often a Dangerous Claim

Laboratory Products for “Research Use Only” (RUO) – Often a Dangerous Claim Manufactures use the “Research Use Only” (RUO) label to declare that their products should not be used in diagnostic proc

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Classification of in-vitro diagnostic medical devices: how to avoid too high a classification

Classification of in-vitro diagnostic medical devices: how to avoid too high a classification With the introduction of EU Regulation 2017/746 on in-vitro diagnostic medical devices (IVDR), in-vitro

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