Medical device approval in Europe
CE marking demands a successful demonstration of compliance with essential requirements of the medical device regulation (MDR 2017/745). 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. Beyond this, we support your specialists during the whole CE approval process.
Medical device approval in the 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 concerning FDA approvals may grant you optimal conditions for your success, especially due to real hands-on support besides sole consultation in regulatory aspects.
|Approval of medical apps
Mobile technologies are 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 a 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 its 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, final management performance is under question by evaluation of overall company process performance in terms of the self-imposed company quality goals.
OPTANA is capable of executing your internal audits in all aspects, from development up to manufacturing and customer support/sales processes.