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.
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.
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.
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