Software Development Lifecycle Regulatory Compliance for Medical Devices
Learn more about the software development lifecycle to increase software safety reliability and compliance with international standards.
Software Development Lifecycle Training
Our software development lifecycle (SDLC) training supports conformity to IEC 62304 and IEC 82304 standards.
EU Update: New Guidance on Clinical Investigation Investigator's Brochures
Medical device makers doing business in the EU should become familiar with the regulatory requirement of providing an investigator’s brochure (IB).
Second Report on the European Clinical Evaluation Consultation Procedure (CECP)
The EC published its second overview of the Clinical Evaluation Consultation Procedure (CECP) (Article 54) of the Medical Devices Regulation (MDR) 2017/745.
Update for EU Amending Regulation and Regulators Who Leverage CE Marking Certificates
Regulators are scrambling to confirm that their provisions regarding leveraging CE Marking Certificates are sufficiently aligned to Regulation 2023/607 by the May 26, 2024 deadline.
Brazil ANVISA Legislation Allows Leveraging Regulatory Authorizations for Medical Devices
Medical device regulator ANVISA published new legislation allowing manufacturers of higher-risk devices to leverage registrations from some foreign regulatory authorities when applying for Brazil market access.
EU Recap: March 2024 was a Month of Many Medical Device Regulatory Updates
Manufacturers should commence their MDR and IVDR compliance journeys now. Emergo by UL recommends manufacturers review the guidance provided by their notified bodies as well as the Team NB Best Practice Guidance on the MDR Technical Documentation File (TDF) and similar guidance for the IVDR TDF.
Effective Date Nears for Brazil ANVISA IVD Regulation RDC 830/2023
Brazil’s medical device regulator ANVISA announced RDC 830/2023 becomes effective June 1, 2024, requiring manufacturers to assess gaps between RDC 36/2015 and RDC 830/2023, and review the classification of their IVDs.
Laboratory Developed Test Manufacturers in the U.S.
In this on-demand webinar, our Emergo by UL subject matter expert will share insights on how to navigate laboratory-developed test manufacturers in the U.S.
Webinar debrief: Applying Human Factors Engineering to Software as a Medical Device
On March 20, 2024, our Senior Research Director Merrick Kossack and Design Director Cory Costantino delivered a webinar on applying human factors engineering to software as a medical device. This debrief highlights some key topics presented.