Mapping Out a Global Human Factors Validation Strategy
Emergo by UL human factors specialists share insights into mapping out a global human factors validation strategy.
Cybersecurity and U.S. FDA Software as a Medical Device Regulations
This white paper provides an overview of FDA cybersecurity control requirements in support of marketing submissions for software as a medical device (SaMD).
Vigilance Reporting in the European Economic Area, Switzerland and the United Kingdom
This white paper explains key compliance issues for medical device manufacturers regarding vigilance reporting across the European Economic Area (EEA), Switzerland and the U.K.
Updates on Israel’s Declaration and Fast-Track Routes for Medical Devices
Israeli regulators have issued new guidelines explaining Declaration and Fast-Track routes for medical device registration in the country.
Overview of India’s Medical Device Regulatory Framework
Learn more about India CDSCO medical device regsistration and approval requirements.
New FDA Guidance: Use-Related Risk Analyses for Drugs, Biological Products and Combination Products
Emergo by UL human factors specialists share insights into recent U.S. Food and Drug Administration (FDA) draft guidance on the purpose and content of URRAs for drugs and medical products.
Summary of FDA’s July 2024 Draft Guidance on URRAs
Emergo by UL's Human Factors Specialist provides insights into the FDA's July 2024 draft guidance on the purpose and content of Use Related Risk Analysis (URRAS)
EU Deadline Approaching for Portable Batteries in Medical Devices and IVDs
Emergo by UL examines Battery Regulation 2023/1542 in Europe, and how medical device manufacturers will be impacted in terms of compliance.
Amendments to the Pharmaceuticals and Medical Devices Act in Japan
This white paper highlights how medical device and IVD manufacturers are impacted with the amendments to the PMD Act in Japan.
SCHEER Updates Guidance on Phthalates in Medical Devices
In Europe, the Scientific Committee on Health Environmental and Emerging Risks (SCHEER) has updated its guidance on Phthalates and the possible restriction of dechlorane plus.