MD-Clinicals

medical devices

About

MD-Clinicals is a specialized company with over 30 years of experience in managing medical device clinical investigations and in vitro diagnostic (IVD) performance studies worldwide. Founded by Danielle Giroud, an expert in clinical research and regulatory affairs, the company operates globally with offices in Switzerland, Germany, China, and Singapore. Their mission is to accelerate medical innovation by assisting manufacturers in bringing their products to market efficiently and in compliance with regulations. The company offers a range of services, including management of global clinical trials, development of regulatory strategies, and market access support. They provide consulting on quality management systems and regulatory requirements across various jurisdictions, along with training programs. MD-Clinicals has successfully completed over 400 clinical investigations and submitted more than 200 clinical evaluation reports, demonstrating their expertise in navigating the regulatory landscape for medical device and IVD manufacturers.

Technologies

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Keywords

pilot studies swiss authorized representative clinical trials clinical evaluation pivotal studies pmcf studies medical writing training clinical evaluation reports clinical investigations clinical strategy regulatory affairs regulatory medical devices clinical strategy development risk assessment recruitment early feasibility studies healthcare equipment and supplies manufacturing data protection clinical data justification consulting regulatory authority liaison management consulting ivd performance studies clinical investigation in china services regulatory pathway product development fda pre-submission

Location

40 Rue des Jordils, Saint-Sulpice, Vaud, Switzerland, 1025

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