Software Simplifies ANVISA, COFEPRIS Regulatory Approval Process
New Emergo by UL software guides you, step by step, through the complex regulatory requirements of these two markets crucial to success in Latin America.
Medical Devices Regulation (EU MDR) Training for Manufacturers
Prepare your team for the regulations and requirements for medical device manufacturers with our on-site and remote EU MDR compliance training courses.
IVD Registration and Approval Consulting
IVD registration and approval consulting in Europe, Australia, Canada and other major medical device markets. Read more on IVD consulting.
On-Site Medical Device Single Audit Program (MDSAP) Training for Manufacturers
Become familiar with country-specific requirements, industry-related terms and what to expect from an MDSAP certification with our on-site MDSAP training.
EU Medical Device Vigilance and Incident Reporting
Learn how we can assist with European medical device vigilance and adverse event reporting, FSCA reports, post-market monitoring and creating vigilance procedures.
Our Consultants
Our consultants can draw on decades of experience in medical device regulatory affairs, human factors engineering, clinical research, and cybersecurity to help you.
Medical Device Vigilance Reporting in Taiwan
Emergo by UL can help you implement a vigilance system for adverse event reporting, recalls and post-market monitoring as required by the TFDA.
Regulatory Consulting for Telehealth and Mobile Apps
Emergo has experience working with medical device manufacturers who make a wide variety of patient monitoring, disease management, PACS imaging, and other software-containing medical devices whose value and effectiveness can be enhanced through mHealth tec
On-Demand Webinars
Leverage our subject matter experts’ insights to stay informed on emerging industry issues and deepen your knowledge of human factors engineering, regulatory requirements and innovative technologies.
ISO 13845 Audit and Training Services for Medical Device Companies
We assist medical device manufacturers with on-site ISO 13845 compliance audits, training services, and eQMS support to evaluate their QMS and GMP processes.