EMMA International Consulting Group, Inc. and Thema srl Announce Strategic Partnership
This Strategic Partnership will enable EMMA International and Thema to Increase Their Geographical Offerings for the Medical Device Industry Bingham Farms, [...]
This Strategic Partnership will enable EMMA International and Thema to Increase Their Geographical Offerings for the Medical Device Industry Bingham Farms, [...]
Last July, 22 FDA published the guideline Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct [...]
Through the document Clinical evidence guidelines for Medical Devices published last June, TGA has finally made available the most significant guidelines [...]
The Person Responsible for Regulatory Compliance (PRRC) is one of the most critical elements of MDR (EU) 2017/745 as the responsibilities [...]
This White Paper focuses on the figure of the European Authorised Representative (EU REP), who plays a fundamental role in the [...]
Performing technical safety tests is a key step in the procedure for accessing the Chinese device market and is particularly critical [...]
During last 5 May preliminary hearing, the Council of Ministers approved the draft of the Legislative Decree adjusting the national legal [...]
This White Paper focuses on the figure of the European Authorised Representative (EU REP), who plays a fundamental role in the [...]
MDCG 2022-6 guidance on Significant Changes to Legacy IVD Devices pursuant to Article 110(3) IVDR was published a few weeks ago. [...]
On 13 April 2022, the European Commission published the notice (Notice To Stakeholders) to regulate trade relations between Turkey and the [...]