Accelerating Innovative Medical Devices to Market
Through better access to information in regulatory compliance, business intelligence, and technology insights
NavBook helps companies identify and build from regulatory information of already market approved medical device relevant to specific product features
NavBook provides access to critical information that typically costs 10s of 1000s of dollars in a cost-efficient way, giving them instant competitive advantages over their competitors.
Easier and Better Search
NavBook allows more accurate search and match for product specificities, reducing the demand for specialist skills and knowledge to access critical information.
Faster, better and more affordable MedTech innovations for the society
Getting regulatory approval is hard
There are about 350,000 digital health apps on the market by 2020. But, in contrast, there are only around 300 apps approved/cleared by the regulatory agencies for the USA and EU markets.
Accessing MedTech Intelligence is costly
Experienced MedTech experts who understand how to access MedTech intelligence add a lot values to a company. However, these insights are often inaccessible to start-ups due to expert shortage and the fact that it costs £1,500 - £2,500/day to have them on board.
Actionable insights to help you to make informed decisions
- Device’s official name approved by the FDA
- First and secondary product classifications and device class
- All applicable US FDA recognised regulations that the product is compliant with
- Premarket submission number/De Novo/PMA number
- Approval date
- 510k predicate devices and dependencies
- Establishment (company) name
- Establishment Address
- Establishment type e.g., manufacturer, specification developer, foreign exporter
- Company owner’s information
Regulatory Data collections
We have worked with some of the UK’s and USA’s leading regulatory experts, innovative MedTech companies, big and small regulatory consultancies, and even the regulators and notify bodies to develop the platform.
It is designed and built by technology innovators for MedTech innovators. That has ensured that we understand the challenges they face when taking a product to market, especially in the early days of development.
We are running a trial user programme and operating a waiting list.
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Meet us in Oxford!
We would love to speak with you.
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NavBook is the outcome of two successful UK government funded research and innovation projects with significant funding contributions from InnovateUK.