FDA AI requests

New forces in regulatory affairs eases the approval process for medical devices

As shown in the graph above, only 31% of all 510(k) applications (Premarket Notifications) goes through the approval process without a request for ‘Additional Information’ (AI) from the US approval authority; U. S. Food and Drug Administration (FDA). This figure clarifies and emphasizes the bureaucratic and often confusing approval process that all medical devices must go through prior to market launch – and which can delay the launch significantly.

Technolution has more than 15 years of experience in the development of medical devices and often deliver inputs to 510(k) applications. We can now offer the same amount of experience and insight within Regulatory Affairs (RA) and approval of medical devices and can draw up applications, undertake dialogue with the FDA and the entire approval process for both large and small medical companies across the country.

The new initiative means that we, as one of the few development companies in the Nordic countries that are certified* according to ISO 13485, can make early predictions of medical device approval as an integral part of development and innovation activities:

  • Concept development and engineering: RA insight will drive the project in a more feasible direction, faster.
  • Usability og Human Factors: With a RA point of view, we ensure that the documentation of usability and human factors are in place and are fully traceably documented.
  • Risk analysis: The risk analysis is integrated and adapted throughout the project cycle to ensure that the final product addresses all potential risks adequately.

We believe that we can navigate more safely in an otherwise complex and constantly changing world. By working proactively and continuously with the process we ensure that you go quickly and smoothly through the FDA approval process – beneficial to both the project timeline, success and your business.

Upscaling our RA-competencies is part of our ambition to be your true all-in-one innovation partner – from A to Z.

*Learn more about our certifications here.

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