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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
Is it possible to self-certificate devices in the field of the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746?
What are the main changes provided for in the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746?
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?
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News
- 21 September 2021 On August 24th ,2021, the UK government decided that mandatory UK Conformity Assessed (UKCA) marking would be delayed to January 1st ,2023, for all the products placed on the UK ...
- 21 September 2021 The US Food and Drug Administration (FDA) has published the fee rates corresponding to fiscal year 2022 (FY2022) starting October 1st 2021 and ending September 30th, 2022, envisaging a 2.5% ...
- 21 September 2021 At the end of June 2021, the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA) presented new details on the next UDI system on Medical Devices in a motion (Consulta Publica ...
- 4 August 2021 In July 2021, the first MDR and IVDR harmonised standards were published in the Official Journal of the European Union. Harmonised rules or “harmonised standards” are European standards valid for all EU ...
- 4 August 2021 The ISO 20916:2019 standard “In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice” provides detailed information on Clinical Performance Studies (CPS) ...
- 4 August 2021 Since the 1st of June 2021 amendments to the Health Supplies Regulation (Reglamento de Insumos para la Salud RIS, which also includes the regulations for Medical Devices) have come into effect in ...