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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 are the MDR requirements for post-market surveillance, market surveillance and vigilance?
What is the “period of grace” and how can I take advantage of it?
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 is the “sell off” provision?
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 in vitro diagnostic medical devices regulation IVDR (EU) 2017/746? When does it apply?
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News
- 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 ...
- 22 September 2020 The Medical Device Coordination Group (MDCG) has recently published some updated guidelines as support for the implementation of the new Medical Device Regulations MDR (EU) 2017/745 and the IVDR (EU) ...
- 22 September 2020 Last July 2020 the Swiss Federal Council approved the revision of the Medical Devices Ordinance (MedDO), along with the new Ordinance on Clinical Trials for Medical Devices (ClinO-MD). Both ordinances ...
- 5 August 2020 The European Commission has published the guideline MDCG 2020-13 : “Clinical evaluation assessment report template (CEAR)”. This is a clinical evaluation report used by Notified Bodies (not for Manufacturers) which explains ...
- 5 August 2020 The second edition of the application guide ISO 14971 “Medical devices – Application of risk management to medical services” was published last June 2020. It is a worldwide-accepted ISO standard ...
- 5 August 2020 The FDA guideline “Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act” on electronic submission for medical ...
- 20 July 2020 Recently, the Chinese Centre for the Evaluation of Medical Devices (CMDE) published two announcements concerning new procedures for the medical devices registration in China. New CMDE procedures for registering medical devices ...
- 20 July 2020 On July 1, 2020, FDA published the update of the “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking” guide ...
- 20 July 2020 On June 26, 2020, CEN (European Committee for Standardisation) and CENELEC (European Committee for Electrotechnical Standardisation) rejected the implementing decision M/565 of the European Commission (EC) published on May 15, ...
- 19 June 2020 Because of the postponement by one year of the date of implementation of the MDR (EU) 2017/745 Medical Devices Regulation (May 26, 2021), the European Commission published a new implementing ...