We help clients design comprehensive strategies and timelines for the introduction of devices to global markets throughout the product lifecycle.
The MCRA team can develop a regulatory assessment/ strategic plan based on your company’s needs and goals. The plan could include:
- An overall regulatory strategy based on device type per market, including identification of the device classification
- A detailed outline of registration processes and requirements, expected regulatory costs, and, if applicable, where device approvals in other markets may be utilized for a faster and/or less scrutinized technical review by regulators
- An evaluation of your company's product portfolio and the best approach for the grouping of implants and instruments for submission and review by the regulatory body(ies)
- A strategic review of the clinical evidence to support each device type and identification of equivalent comparator(s) where necessary