To get your medical devices to market requires navigating a maze of regulations. The type of product and where it is to be sold determine the paths that will lead to a successful product introduction. Product or labeling changes can also thrust you back into the maze. Getting lost can cost time and money.

Key Benefits

• We know these waters and can help define a regulatory strategy before you do the development work.
• We can help you to avoid common pitfalls that may invalidate your submission.
• We can help you choose what to claim to avoid additional scrutiny or requirements.

Capabilities

We've participated in or individually done many submissions. We can work with your engineers to craft the whole thing, or collaborate with your RA department to help them with questions or issues.

First

Define a regulatory strategy based on the device being developed, its intended use, and its markets.

Then

Write the submission(s) and organize the supporting documentation.

Finally

Review changes to the device or its labeling to assess whether new submissions are required.

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Copyright © 2007 NJK & Associates, Inc.
Last modified: 04/01/10