Medical device approval in Europe
CE marking demands successful demonstration of compliance with European directives (MDD 93/42/EEC or 98/79/EC). For products with higher safety classifications (2a, 2b, 3) the manufacturer will at least be monitored annually by a Notified Body.
With our experience gained during numerous product approvals and an international network of specialists in the background, OPTANA develops adequate approval strategies and beyond this serving with real hands-on support and on request also immerse into the technical details supporting your specialists during the whole CE approval process.
Medical device approval in USA
FDA approval is the first cornerstone to enter the US market. Depending on the level of concern (Class I, II or III) the approval process may end in enormous complexity and demands from the FDA, thus, requiring a clear approval strategy.
OPTANA's long lasting experiences with respect to FDA approvals may grant you optimal conditions for your success, especially due to real hands-on support beside sole consultation in regulatory aspects.
|Approval of medical apps
Mobile technologies is on the rise! It is increasingly used for medical purposes e. g. perfectly adapted to the upcoming demands of patient compliance. As medical Apps can have severe impact on the patient's health respective solutions must be classified and approved against legal standards and regulations.
Optana is a legal manufacturer and forerunner in this technology with own mHealth solution! We are willing to pass on our know how for your success.
|Supplier auditing and qualification
In the light of the enforced unannounced supplier visits by Notified Bodies the company's supplier relationship must be assessed, regulated and supervised more than ever.
Different supplier relationships may be settled depending on the supplier maturation and certification state. Outsourced quality relevant processes will be analyzed and Optana will set up the required quality assurance agreement together with you.
Strategic supplier management is essential for your next scheduled notified body surveillance!
Established quality systems must routinely be audited, preferably executed by independent external experts. During the internal audit, finally management performance is under question by evaluation of overall company process performance in terms of the self imposed company quality goals.
OPTANA executes internal audits returning to you driving factors to match your company goals in all aspects, from development up to manufacturing and customer support / sales processes.