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Scooteat was launched in 2012 as a consulting company for medical device certification. We provide technical and strategic advice for small business wanting to enter the European market. Our principal field of expertise is related to maxillo-facial and dental surgery.
A quality system for medical companies
ISO 13485 certification is the key for selling medical devices in the European Union market. Obtainng this certification is often seen as time/money consuming. This is especially true if the certification process is performed by people without experience of the EU Medical Device Directive/Regulation.
A comprehensive description of what you produce
Redaction of a medical device technical file is a complex exercise requiring skills in engineering, quality assurance and medical field. Moreover, having an appropriate structure speeds up the analysis and approval by the notified body.
A completely different job
Selling medical devices in European Union requires an effective network of representatives. Building such a network requires much time and knowledge of the different countries. Accessing a well established network helps to increase quickly the turnover.
Confidence and discretion
We always consider that discretion is very important for our customers. That's the reason why we don't place their name or logo on our advertising. Taking contact with us will convince you of our added value for your business.