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 has operated for a long time in relation to both types of devices and it has developed over time a wide ability to meet the need of companies, both technical and regulatory.
Medical devices and IVD consultancy supports the firm for the constitution of the product technical file and the development and application of a quality management system, in accordance 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 the affixing of the CE marking -from the 5th of May 2017 – is regulated from:
- Regulation 2017/745/EU that will replace the European Directive 93/42/CE by spring 2020
- Regulation 2017/746/EU that will replace the European Directive 98/79/CE by spring 2022.
For the export of a medical device to the United States the FDA clearance is required according to the applicable CFR (Code Federal Regulation).
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.