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 [...]
