A young UK based medical device company that had successfully CE marked a novel device asked our consultant to lead the regulatory submission in the USA to obtain 510(k) clearance.
A young medical device company had successfully CE marked a novel lung function device, and the next step in the commercial strategy was to obtain 510(k) clearance to market in the USA. This was a complex submission that required careful planning in order to expedite the approval process while at the same time maximising its use over a number of potential measurement parameters.
Our medical device regulatory consultant worked closely with the client’s product development and clinical teams to develop a strategy that balanced timelines and cost against the delivery of a marketable product that offered competitive advantages over existing products on the market. The initial part of this process involved taking a Pre-Submission route in order to gain feedback from the FDA on the proposed strategy.
Our lead regulatory medical device consultant on this project has over 20 years’ experience operating in regulatory affairs across multiple medical device specialities. She has authored numerous successful FDA submissions including original PMA’s, a modular PMA, an HDE, several original IDE’s, pre-IDE’s, PMA and IDE Supplements and 510(k)s for novel products including implantable devices, multiple sensor monitoring tools and diagnostic devices. She has also worked on projects for clients with novel Class II and Class III IVD, diagnostic, therapeutic devices and drug device combination product.
We are a specialist medical device consultancy consisting of industry experts with long and successful track records in commercialising medical device products. We have broad functional and sector experience, and would welcome an opportunity to discuss with you any challenge relating to creating sustainable value from medical technologies.
Mark Wickham of Alacramed will be attending Med-Tech Innovation Expo 2019 at
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Alacramed Ltd, St Johns Innovation Centre, Cowley Road, Cambridge,
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