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Approval of Medical Products

A medical device is used in or on humans and brings a degree of risk. To meet the demands of a uniformly high level of protection, directives were created, inter alia by the European Union and the FDA guidelines, to regulate putting medical devices on the market and to guarantee safe operation of medical devices. The medical devices must meet the conditions laid down in the (essential) requirements of the directives.

In Europe, a conformity assessment procedure must be carried out prior to marketing, which confirms compliance with all relevant requirements. In medical software, these include, inter alia, requirements for documentation, the software development process, software testing, software validation (EN 62304), suitability for use (IEC 60601-1-6 / EN 62366), risk management (ISO 14971), version management, and, depending on the product, even more specific requirements such as IEC 80001 ("Risk management for medical IT networks"). Depending on the risk class of the medical device, the Declaration of Conformity can be issued directly by the manufacturer (for risk class I) or only after testing by a Notified Body (for risk category II and III). For medical products in risk class III, clinical trials also are needed.

In order to be able to offer a medical device such as a medical app in the USA, one must satisfy the guidelines of the US Food and Drug Administration (FDA) and use a quality management system in accordance with 21 CFR Part 820. If there are already comparable approved products, a US FDA 510 (k) Premarket Notification can be submitted, otherwise a "De Novo" 513 (g) application must be made, unless it is a low-risk product in class I, which can be exempted from the authorization procedure before the launch.

 

We are happy to assist you with the approval of your medical devices. We serve more than 500 customers from the pharmaceutical and medical technology sector and specialize in the development of medical (standalone) software and medical apps (iPhone, iPad, Android & Windows 8) in accordance with IEC 62304, ISO 13485, ISO 14971 and EN 62366. We support our customers in all product lifecycle phases: requirements engineering - risk management - software engineering - usability engineering - testing - rollout - publication in app stores - CE marking / FDA approval - market monitoring.

 

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