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.
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).