Substance-based medical devices: What you need to do now in order to continue marketing your legacy device under the MDR

Regulatory Affairs, Systems Engineering for Medical DevicesLeave a comment

  Manufacturers of substance-based medical devices such as seawater nasal sprays, mucous membrane-soothing cough syrups, or osmotically active laxatives face several challenges once the Regulation (EU) 2017/745 (MDR) came into force: This article illustrates what can be done to overcome the regulatory hurdles and ensure the marketability of your substance-based medical devices beyond the transition…

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Verification and validation of IVD medical devices

Systems Engineering for Medical DevicesLeave a comment

IVD medical device validation confirms the device’s medical purpose. IVD medical device verification, on the other hand, proves whether the IVD works as intended. In this article, we provide a five-step guide on how to carry out the verification and validation of your IVD medical devices in a targeted manner and without unnecessary effort. We…

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INMETRO and ANATEL certification: A requirement for authorization in Brazil?

Regulatory AffairsLeave a comment

When ANVISA registration is no longer sufficient As a manufacturer, there are some hurdles you have to overcome before selling your medical device in Brazil. The best known is registration with ANVISA. In addition to this, you may also need INMETRO or ANATEL certification for your device. Manufacturers should be aware of the cases in which they must…

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Planning sample sizes for clinical studies of medical devices and IVDs: The 6 questions your statistician must answer

Healthcare & Health IT, Regulatory AffairsLeave a comment

If you have to conduct a clinical investigation for your medical device or clinical performance study for your IVD, you won’t be able to avoid sample size planning. And you will need to avoid the following two problems when calculating the sample size: Therefore, you need to accurately identify the exact sample size needed so…

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Clinical evaluation of software: Three proofs of conformity

Regulatory Affairs, Systems Engineering for Medical DevicesLeave a comment

The same legal requirements apply to the clinical evaluation of software as to the clinical evaluation of all medical devices. This means that as a Medical Device Software (MDSW) manufacturer, you must prepare a clinical evaluation for your product just like any other manufacturer. A performance evaluation must be carried out for software that is an in vitro diagnostic…

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International medical device authorizations: 5 steps to new markets

Regulatory AffairsLeave a comment

A lot of medical device manufacturers see the international authorization of their device as a potential hazard: the opportunities offered by new markets are offset by hard-to-calculate risks as well as the time and costs required for these authorizations. The five steps presented in this article will help manufacturers to manage these risks better. And this is…

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Quality Assurance Agreement (QAA)

Quality Management & ISO 13485Leave a comment

A Quality Assurance Agreement (QAA) is a contract between companies such as medical device manufacturers and their suppliers (subcontractors). In these contracts, both parties regulate which obligations the suppliers must fulfill regarding the quality of the devices and services supplied. Find out in this article what content a Quality Assurance Agreement should contain and when…

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The clinical evaluation literature search: 6 tips to save you time and stress

Regulatory AffairsLeave a comment

The literature search is a key part of the clinical evaluation. It usually involves numerous hours of work. This article will give you six tips to help you efficiently carry out and fully document the literature search. In the literature search, manufacturers gather together scientific articles, among other reasons, to document the state of the…

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