Understanding Technical Documentation Under MDR
In our recent webinar, part of our four-part MDR and IVDR compliance series, we explored the complex and…
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Navigating COFEPRIS: Medical Device Distribution in Mexico
Mexico is one of the largest importers of medical devices in Latin America yet the importation process is highly…
HPRA Update: Economic Operator Registration Verification
The HPRA (Health Products Regulatory Authority), has posted a regulatory update regarding verification of economic operator registration details…
New COFEPRIS Guidelines for Good Manufacturing Practices
In an effort to streamline processes and strengthen the certification of medical devices in Mexico, the Federal Commission…
Swissmedic Requirements: Device Notifications for Manufacturers
Swissmedic, which is affiliated with the Swiss Federal Department of Home Affairs, is responsible for the regulatory oversight of…
Key Changes to Medical Device Registration with MHRA
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has implemented important updates to the registration process for medical devices.
EU MDR & IVDR: Certificates with Conditions to Support Innovation
The EU Medical Device Regulation (MDR) 2017/745 and the In-Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746 provide a mechanism that…
FDA Increases Oversight on Data Integrity for Device Submissions
The U.S. Food and Drug Administration (FDA) is the U.S. government agency responsible for protecting public health by…
EHDS Regulation Published: Key Benefits for EU Healthcare
The European Health Data Space (EHDS) Regulation ((EU) Regulation 2025/327 amending Directive 2011/24/EU and Regulation (EU) 2024/2847) has…
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