Regulatory Affairs Consultation for Medical Device Companies

Whether you’re preparing for a regulatory submission of a new product or looking to better understand and comply with local regulations, Kapstone can help—as early and as often as you need us. After decades of regulatory experience in the medical device industry, we can say that regulatory affairs should play a significant role throughout the entire product lifecycle -- starting in conceptualization, progressing through regulatory submission, and continuing with line extensions.

We’re experts in many of the major market regulations. We can step in at any point in the product lifecycle process. Bring us on board early and we’ll help you position your new product for compliance right through the finish line to ensure that your activities and documentation are ready for review by any regulatory body.

Regulatory Strategy

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.

Regulatory Submission

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.

Compliance Remediation

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 Training

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.

What Our Clients Are Saying

I started a very complex project with Kapstone. What I found was a group that was incredibly responsive to my needs and receptive to my ideas.

Dr. Garcia Bengochea, Neurosurgeon
What Our Clients Are Saying

Kapstone has done a marvelous job. Everything from prototyping, intellectual property development as well as helping me get to market.

Wyatt Geist, CEO, Safewire Inc.

See Our Process in Action

Download our New Product Development (NPD) Roadmap to take a deeper dive into our seamlessly integrated process.