There are published guidance documents including checklists on how medical device manufacturers can demonstrate cybersecurity compliance. Checking your devices against these guidelines can help you prepare your technical files for submission and auditing.
The MDCG has released a revised document, MDCG 2022-4 Rev 2, Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD. This guidance document outlines the activities to be performed by notified bodies as part of the appropriate surveillance defined in Article 120(3e) MDR.
Under the MDR 2017/745, medical devices are classified into different classes based on their intended use and potential risks to patients. The MDR also includes additional requirements for certain devices, including borderline products.Borderline products are those that have characteristics of both medical devices and other products such as:– Borderline between medical devices and medicinal products,– Borderline between medical devices and substances of human origin– Borderline between medical devices and cosmetic products– Borderline between medical devices and personal protective equipment It’s important to understand the mode of action of the product to truly determine the regulatory framework. Incorrectly classifying a product can result in huge financial loss. In the case of borderline products, careful assessment[…]
Choosing the right Notified Body for certifying your medical device is important. Factors such as costs, Notified Body review times should be considered when making this decision. We work with many Notified Bodies across different device groups.
The FDA Breakthrough Devices Program speeds up medical device development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization.
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CMS can help you with your internal audit. Contact us to book your next internal audit. We are also hosting a three-day Auditor training session on May 14-16 2024. Contact us to book your spot.
