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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”
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
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?
Transitional period: can in vitro diagnostic medical devices, conform to the current IVDD, be placed on the EU market after May 26, 2022?
How does the Regulation on in Vitro Diagnostic Medical Devices (IVDR) affect the Quality Management System?
Homepage
Countries
Countries
News
- 25 March 2021 On 15 February 2021, the European Commission published the “Management of Legacy Devices in EUDAMED” document to explain how legacy devices are identified in EUDAMED, that is how the different Unique Device ...
- 25 March 2021 In the notification published on 5 February 2021 in the Official Gazette, the India’s Ministry of Health and Family Welfare (MoHFW) proposed to recognise methods and standards of the American Society for ...
- 25 March 2021 The Thai Food and Drug Administration (Thai FDA) has issued new rules on classification and registration of Medical Devices and IVDs. New THAI FDA rules on device classification and registration New Medical ...
- 22 February 2021 In order to increase the availability of certain Medical Devices in contrast to the COVID-19 health emergency, on January 15, 2021 FDA published a notice in the Federal Register which ...
- 22 February 2021 It is approaching the deadline for the MDEL renewal, the Medical Device Establishment Licence in Canada. MDEL license renewal within 1 April and commissions update for MD According to the Guidance on ...
- 22 February 2021 Below there are the latest news on the regulatory updates of Medical Devices in some South-East Asian markets of particular relevance and interest. Medical Device regulatory updates in Philippine, Vietnamese and Malaysian markets Philippines: ...