STRATEGIC REGULATORY CONSULTING

A key factor for success in developing a new medical device technology is identifying the optimum route to EU market approval and reimbursement.

And, with the implementation of the new Medical Devices Regulation (MDR) and other changes that are rapidly occurring in the market, this can be a challenging task.

MedPass has the up-to-date knowledge and experience to help clients determine the most efficient and costeffective pathways to medical device regulatory approval and reimbursement in Europe. Whether the goal is to conduct a clinical trial, obtain market approval, funding or reimbursement, we help our clients develop strategies that reduce timelines and increase cost efficiencies.

With over 25 years of experience, and a proven track record of helping bring to the market some of the most important breakthrough technologies in recent years, from transcatheter heart valves to genomic sequencing IVDs, MedPass helps answer the key questions impacting successful device development and market access of a new medical device technology:

  • What will change under the new Medical Device Regulations (MDR)?
  • What clinical evidence will be needed for regulatory approval, market access, PMCF?
  • What are the most favorable sites/countries for performing clinical investigations?
  • Which Notified Body best meets the company’s needs?
  • Is there any existing coding, payment, reimbursement for the technology?
  • What health economic data will be needed for market access in key European markets?

Our customized roadmaps ensure that clients fully understand the opportunities and hurdles of bringing a new medical device technology to the EU market.

From the early stages of product development through the post market phase, MedPass’ strategic consulting team is responsive, providing quality, expert advice to guide clients through all stages of the regulatory and reimbursement process.

Our strategic consulting team is diversely skilled and professionally trained in key areas such as clinical evaluations, risk management, biocompatibility, biomedical engineering, quality management systems, medical writing, tissue products, biostatistics, healthcare economics, reimbursement, and innovation funding.