Understanding MDR and IVDR Post Market Surveillance
Explore key elements of Post Market Surveillance (PMS) under MDR and IVDR in our latest webinar.
Resources & News
Stay informed with real-time regulatory news and expert insights, and keep the conversation going by connecting with us on social media.
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Technovigilance: PMS Reporting Requirements in Mexico
Learn about technovigilance requirements in Mexico for medical devices, including COFEPRIS compliance, adverse event reporting, and more.
New EU Revised Manufacturer Incident Reporting Form
Discover the latest updates in EU Manufacturer Incident Report (MIR) Version 7.3.1.
Two New Notified Bodies Added Under the IVDR (EU 2017/746)
Two new Notified Bodies have been added under the IVDR...
Team NB Position Paper: IVDR Certification Process
Team NB IVDR certification guidance outlines pre-application and application procedures for IVDs.
New Team NB Position Paper on EU AI Act
Team NB’s updated position paper on the EU AI Act outlines key implementation challenges and solutions for medical devices.
Swiss Medtech Holds US Tariff Webinar
Swiss Medtech is now offering a webinar on US Tariffs on May 21 to explore the impact of US tariffs on the medtech industry.
New Open Letter to European Commission Regarding US Tariffs
European Commission urged to act on US tariffs threatening Europe's medical technology sector.
New FDA-Approval Process for Swiss Device Market Entry
Learn about the Swiss FDA approval process as the Swiss government works to simplify medical device regulations.
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