All medical device manufacturers need a regulatory strategy, and they need it very early in the product development schedule a defined, clear path to bring the product to market. We have helped start-ups and mature companies identify the device's classification, the standards required to be met, and the regulatory pathway to success.
In need of assistance with a 510(k), PMA, or de novo? 
BioVision provides expertise for all medical device regulatory pathways for manufacturers and importers that want to market their products in the U.S. Not in the US? 

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For medical device manufacturers looking to sell into the European Union, the challenges have become even greater. Significant revisions to the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) place greater responsibility on manufacturers and distributors to ensure the quality and safety of the products they sell. Obtaining a CE Mark requires the know-how to interpret the MDR and present information specific to each country's requirements. We have written technical files and clinical evaluation reports for all medical device classes and will help you prepare for your Notified Body meetings and audits.

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For all medical device designers and manufacturers, feedback from FDA is valuable. The Pre-Submission (or Q-Submission) process is geared at obtaining that feedback. BioVision has vast experience with preparing the requests and conducting these meetings with you or on your behalf.