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Quality&Regulatory Affairs for Medical and In-Vitro Diagnostic Devices
Mission
THEMA offers strategic and regulatory consulting to medical device IVDs and regulatory-related companies.
THEMA aims to help the Customer to achieve his own commercial purposes, using a reliable and competent regulatory specialist partner.
THEMA supports national and foreign companies with needs, projects, possibilities and different aims that want to place their devices on national and international markets in compliance with regulations.
Our team has the required professional skills and competencies to perfectly understand Customer’s needs, products and services, by acting quickly and in the most suitable manner.
Our branches and international partners collaborate with us to find out the solution that best suits Customer’s specific needs, protecting even his interests.
Quality&Regulatory Affairs for Medical and In-Vitro Diagnostic Devices
FAQ
What is a regulatory strategy
How do I register medical devices in the world
Why is the CE marking required
What are the GMP requirements
How to register radiation emitting medical devices with the CDRH
MDR (EU) 2017/745 impact on CE MDD certificates during the “period of grace”
IVDR (EU) 2017/746
When do Manufacturers of in vitro diagnostic medical devices have to conform to the IVDR (EU) 2017/746?
What is the in vitro diagnostic medical devices regulation IVDR (EU) 2017/746? When does it apply?
What is the “sell off” provision?
Is it possible to self-certificate devices in the field of the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746?
Swiss – Exit: requirements to market Medical Devices in Switzerland
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Countries
News
- 20 December 2021 The Implementing Regulation (EU) 2021/2078 of November 26th, 2021, published on the Official Journal of the European Union, lays down application rules for European Parliament and Council MDR (EU) 2017/745 Regulation on EUDAMED, European ...
- 20 December 2021 In October 2021, the Medical Device Coordination Group (MDCG) published the “Joint implementation and preparedness Plan for Regulation on in vitro diagnostic medical devices (IVDR)”, an update of the Implementation ...
- 20 December 2021 In the past few weeks, the Australian Regulatory Authority – the Australian Therapeutic Goods Administration (TGA) – has published some guidelines and important updates on clinical evidence, reclassification of some devices and a project ...
- 29 November 2021 UPDATE OF 20 DECEMBER 2021 UPDATE IVDR (EU) 2017/746. Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation! The European Council have join the Parliament in adopting the proposal for ...
- 29 November 2021 On October 26, 2021, the US Food and Drug Administration (FDA) Centre for Devices and Radiological Health (CDRH) published the guidance document for fiscal year 2022 (FY2022) and the CDRH ...
- 29 November 2021 Saudi Food and Drug Authority (SFDA) – Regulatory Authority of Medical Devices market in Saudi Arabia – aims to increase patients’ safety by optimizing devices traceability. As a consequence of ...