Medical device companies sometimes think of regulatory affairs as a faraway part of the development lifecycle. Why worry about FDA medical device regulation when you don’t even have an engineer available to work on your project? Why familiarize yourself with EU medical device regulation when you haven’t aligned on your device’s intended use?

While regulatory submission and approval occur towards the end of the development lifecycle, companies can save time and money by integrating regulatory affairs early and often.

We do just that at Kapstone, leveraging our decades of experience to help our clients:

• Create a regulatory plan at the concept stage, outlining a streamlined path to regulatory clearance/approval and preservation of intellectual property
• Identify predicate devices to further streamline regulatory approval
• Identify required tests for each global market, avoiding wasteful spending on unnecessary tests and ensuring critical tests are not omitted
• Differentiate between requirements for US and EU submissions (and other markets)
• Liaise with regulatory bodies
• Prepare required documentation

Kapstone’s regulatory specialists can step in at any stage in the development or lifecycle process. While we recommend integrating as early as possible, we can support closer to the submission time or when adding a new market to an already established device.