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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.
Mission
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”
What is the “post-market surveillance system”?
What are the MDR requirements for post-market surveillance, market surveillance and vigilance?
What is the difference between market surveillance, post-market surveillance (PMS) and vigilance?
How can I continue to sell my devices after the full implementation of MDR?
IVDR (EU) 2017/746
What are the main changes provided for in the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746?
What is the in vitro diagnostic medical devices regulation IVDR (EU) 2017/746? When does it apply?
How does the Regulation on in Vitro Diagnostic Medical Devices (IVDR) affect the Quality Management System?
When do Manufacturers of in vitro diagnostic medical devices have to conform to the IVDR (EU) 2017/746?
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Countries
Countries
News
- 16 December 2020 Last November 2020, the Medical Device Coordination Group (MDCG) published the guideline MDCG 2020-16 “Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746” to explain ...
- 16 December 2020 Last month, the U.S. Food & Drug Administration (FDA) published online information on Certificate for Device Not Exported from the United States (CDNE). This is a new form of certification designed for Medical ...
- 16 December 2020 Last 19 October 2020 the Health Sciences Authority (HSA), Singapore’s Regulatory Authority, announced that it will be introduced a UDI (Unique Device Identification) system to be used for Medical Devices. ...
- 24 November 2020 Last August 2020 the Medical Device Coordination Group (MDCG) published the document MDCG 2020-15 “MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single ...
- 24 November 2020 On 16 October 2020 the Center for Devices and Radiological Health (CDRH) of FDA published the list of guidelines it intends to publish for fiscal year 2021 (FY 2021).Moreover, CDRH ...
- 24 November 2020 On 18 September 2020, the National Health Surveillance Agency of Brazil (ANVISA) published the Resolution RDC n. 423/2020 declaring the elimination of the Cadastro system for the registration of Class II ...
- 22 October 2020 As already happened for the Medical Devices Regulation MDR (EU) 2017/745, the European companies are mobilizing to request the postponement of the full application of the In Vitro Diagnostic Medical ...
- 22 October 2020 On September 1, 2020 the Medicines and Healthcare products Regulatory Agency (MHRA) published new rules to be respected for placing and the registering a medical device on the UK market, ...
- 22 October 2020 On September 3, 2020, the Indian Central Drugs Standard Control Organization (CDSCO) published the “Notice regarding classification of non notified medical devices” which presents new categories for the classification of ...
- 22 September 2020 At the end of July 2020 the European Commission published a guide to address the issue of frequent non-compliance with instructions for use (IFU) for reusable and re-sterilizable medical devices. The ...