Medical devices and IVD consultancy
The Studio tau activity in relation to regulatory affairs has started in one of the most critical areas: medical devices and IVD.
Studio Tau is operating since a long time in relation to both types of devices and it has developed specific models to meet the needs of companies, for both technical and regulatory issues.
Our consultancy supports the firm for the constitution of the product technical file and the development and application of a quality management system, in conformity with ISO 13485 and GMP instructions.
Even if the requirements are substantially the same, the way of submitting the documentation changes according to the regulatory arrangements in force in the different markets of interest.
In Europe CE marking is regulated by:
- Regulation 2017/745/EU replacing the European Directive 93/42/CE on May 2021 for medical devices
- Regulation 2017/746/EU replacing the European Directive 98/79/CE on May 2022 for IVD devices.
For the export of a medical device to the United States the FDA clearance is required according to the applicable CFR (Code Federal Regulation) requirements.
For the export of a medical device to Russia, the achievement of the authorization ROSZDRAVNADZOR is needed; this is released based on laws and specific regulations.
Whatever is your demand in this sector, Studio tau can effectively support you.