Commercializing a new medical device involves more than a business plan and an engineering plan. In order to execute an efficient regulatory submission with the entire product development team, the strategy should be thought-out from the onset and evolve as appropriate. Let Kapstone formulate a comprehensive regulatory strategy for your next product development project.
In conjunction with developing a regulatory strategy, we can guide and execute on the regulatory submission compilation. We leverage our decades of experience and 100+ prior submissions to increase the chance of an efficient (and successful) regulatory review. Whether targeting either side of the Atlantic Ocean or somewhere else across the globe, Kapstone can support your regulatory submission.
As the US, EU, and other markets continually adapt their regulatory requirements and paths to approval, you’ll have to do the same. Effects from M&A activity often leads to melding of different quality systems, creating compliance gaps. Kapstone can help you achieve and maintain compliance, identifying quick pivots or implementing an efficient change management protocol.
Regulatory affairs is a team event. Many people in your organization are affected by requirements of a medical device company, and it’s important that the team is properly aware of on-going tasks and activities. Kapstone can train your internal team on many of the necessary steps to maintain compliance and establish a high level of quality.