Accelerate your medical device’s route to market: Consider the regulatory pathway early on
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This whitepaper discusses how medical device start-ups can accelerate their route to market by considering the specific regulatory pathway early on
To gain regulatory approval for a new medical device, you must demonstrate the product is safe and performs as intended. However, identifying and navigating the relevant regulations can be challenging.
Your regulatory pathway will be determined by your product’s intended purpose, its functional characteristics, and its market. Once you’ve identified that pathway, you’ll know what requirements you need to meet and the evidence you will have to gather.
The scale of this work can be significant. Navigating it is often low on the priority list for innovators. Inevitably, frustration ensues when unexpected requirements cause delays and extra costs.
To make your journey to market as predictable and painless as possible, it’s vital you understand as soon as possible what you need to do and by when you need to do it.
This whitepaper covers the following key topics:
Why it’s important to consider the regulatory pathway of your medical device early
A 5-step process to identify your pathway
How RegNav can help streamline this process
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Author: Michael Kipping
Michael is our Director of Medical Technologies in EMEAA. He has over 17 years of experience working at companies like Boston Scientific and BIOTRONIK and has spent ~7 years helping start-ups launch safe medical devices as part of MHRA and Innovate UK.
Author: James Pink
James is our Senior Director of Global Medical Technology Testing, Inspection, and Certification. He is an accomplished technical expert with a 25-year career in medical technology product safety and market access and has audited hundreds of medical device companies as part of the European CE marking requirements.
