Health Canada Adverse Event Reporting for Medical Devices
Learn how to meet compliance with Health Canada's medical device adverse event reporting requirements.
Australia TGA Regulatory Consulting for Medical Device Manufacturers
Learn how the Therapeutic Goods Administration (TGA) regulates medical devices in Australia and how to become CE-certified in the device registration process.
FDA QSR Audits for Medical Device and IVD Companies
Learn how we can assist medical device and IVD companies in complying with QSR audits and implementing a quality management system under current GMP standards.
White Papers
Our industry-leading research will share insights for success in a dynamic and demanding market.
EU MDR Readiness Assessment Checklist
Use this short checklist to assess what your medical device company needs to do to comply with the EU MDR.
Guides
An in-depth look at industry topics.
Process Charts
Download market-specific overviews of regulatory approval processes for medical devices and IVDs to help chart your product registration. All charts are available to download from Regulatory Affairs Management Suite (RAMS).
Market Data
Review general overview about medical device and IVD regulatory requirements by market and find helpful links to regulatory bodies that govern that market.
Press Releases
Read the latest press releases about Emergo by ULs' efforts to help make the world safer, more secure and more sustainable.
FDA Q-Sub Consulting and Pre-Sub Guidance for Medical Devices
Our US consulting team has extensive experience with the FDA Q-Sub process for medical devices. We can assist you with this critical step as part of the FDA clearance process.