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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
How does the Regulation on in Vitro Diagnostic Medical Devices (IVDR) affect the Quality Management System?
Transitional period: can in vitro Diagnostic Medical Devices, conform to the current IVDD, be placed on the EU market after May 26, 2022?
What is the “sell off” provision?
What is the in vitro diagnostic medical devices regulation IVDR (EU) 2017/746? When does it apply?
Swiss – Exit: requirements to market Medical Devices in Switzerland
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News
- 21 June 2022 Performing technical safety tests is a key step in the procedure for accessing the Chinese device market and is particularly critical in the case of electro-medical devices. This is because tests ...
- 21 June 2022 MDCG 2022-8 Application of IVDR requirements to legacy devices Regulation (EU) 2022/1121 extended the transitional provisions of the IVDR Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDs) by amending ...
- 20 June 2022 During last 5 May preliminary hearing, the Council of Ministers approved the draft of the Legislative Decree adjusting the national legal framework to MDR (UE) 2017/745 and IVDR (UE) 2017/746. ...
- 30 May 2022 MDCG 2022-6 guidance on Significant Changes to Legacy IVD Devices pursuant to Article 110(3) IVDR was published a few weeks ago. EUROPE: guidance MDCG 2022-6 and Significant Changes in Period Of Grace IVD legacy: ...
- 30 May 2022 On 13 April 2022, the European Commission published the notice (Notice To Stakeholders) to regulate trade relations between Turkey and the European Union and ratify the provisions of the Customs Union Agreement. TURKEY: Customs ...
- 30 May 2022 ANVISA -Brazilian Regulatory Authority – published the RDC 665/2022 (entered into force last 2May 2022). This resolution rewrites the BGMP (Brazilian Good Manufacturing Practices) requirements for medical devices and IVDs, ...