tecurat GmbH – Specialists of the industry for the industry
Profitable
We prepare you to launch and successfully position your safe medical device on the intended target market – quick and compliant with the rules
During the development
In continuous exchange, we update the technical documentation as an optimal test preparation. – So innovation can take hold again.
Supporting
We aid in communication with notified bodies & authorities and guide the simplified compilation of all necessary documents.
You have international plans and stumble at the hurdles CE, FDA, ANVISA, CMDCAS, MDSAP or SFDA?
The grueling sprint to document finish should be avoided for future authority communication?
Do you need a mediating & neutral voice in the communicative exchange with the Admissions Office?
Then take advantage of our know-how around the international regulations for medical devices. Make an appointment with us!
Integral part
Approval per se is not a separate process in the life cycle of a medical device. Rather, the obligation of documentation is to be viewed as integral part of development, in which the simultaneous participation of all departments and stakeholders involved in the manufacturing process is necessary.
Thus the application for approval should not hold up your entire company and bring your day-to-day business to a standstill. We support you in developing a suitable approval strategy (medical device, IVD, combination products, machines, etc.). This includes, among other things, the identification of the applicable standards with (harmonized) norms, directives & guidelines.
Iterative process
Product monitoring is an essential part of updating your technical documentation. This includes all associated corrective measures, such as the correction of identified deficiencies & their feedback root cause research & incorporation of PMS / PMCF results into the current development processes.
The associated risk analysis & assessment is a particular concern for us.
Solely the consideration, integration & processing of all reported and observed risks can maintain an acceptable benefit-risk ratio for the patient.
Digitization
Simplify the navigation through your product’s development history for authorities. Shorten the processing time of your approval application and thus valuable resources through a company-coordinated document & development management.
We are happy to be there for you
Meet up with us:
In the office or online – or send us an email whenever you want.
We look forward to meeting you!
+49 331 600 87 640
+49 331 600 87 640
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