Regulatory approval of class II and III medical devices

Company

The client company specializes in the development and implementation of remanufacturing processes of medical devices and has already established itself as a market leader in the European market. The company’s ulterior motive is to increase the circular economy, safety and sustainability in medical facilities through innovative, forward-looking and certified processes.

Competence area

Regulatory affairs

Project tasks

• Coordination of approval projects for medical devices (CE and FDA) in close cooperation with the research and development department
• Preparation, updating and maintenance of technical documentation and design dossiers for EMA and FDA respectively
• Communication with regulatory authorities, cooperation partners and external service providers as well as internal departments
• Active participation in audits and FDA
• Close cooperation with industry associations
• Preparation and submission of premarket notification 510(k) for class II products in close cooperation with cooperation partners in coordination with US FDA
• Preparation of Investigational Device Exemption (IDE) and PMR submissions for Class III products to the US-FDA

Project duration

4 months

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