Learn more about how Medpace will bring your medical device to market safely, effectively, and efficiently.

Exclusively dedicated to helping our medical device clients bring products to market safely effectively and efficiently
Exclusively dedicated to helping our medical device clients bring products to market safely, effectively and efficiently. ...
Streamlined Operations Our operational experts oversee pre market post approval and post market device trial management We streamline the entire study process and ensure our personnel have the tools and processes in place to minimize delays proactively identify risk areas and implement strategies for success Regulatory development planning and submission support Our regulatory affairs team understands the challenges you face when embarking on the development of a new technology We can provide guidance on the likely regulatory pathway through focused discussions and if required can coordinate and lead meetings with appropriate regulatory bodies And if you intend to obtain approval in more than one country our clinical and regulatory experts are experienced in developing strategies that ensure data can be used for multiple country submissions creating significant efficiencies Our device headquarters in Europe is ISO 9001 certified and can serve as your European authorized representative Clinical Services Assess clinical data needs Early Device Development Regulatory strategy including Device classification Notified body discussions Pre submission FDA Meetings Full service trial management Clinical Studies Regulatory approval documents Interim and final reports Clinical study report preparation Clinical literature reviews EU Full service trial management Regulatory Approval Prepare technical files design dossiers Develop quality system including gap analysis internal audit EU authorized representative services Post market Studies Prepare regulatory approval applications EU registrations notifications Quality Regulatory Services 5
Streamlined Operations Our operational experts oversee pre-market, post-approval and post-market device trial management. ...