US FDA Reorganizes Medical Device Guidance Databases
This regulatory update discusses how the U.S. Food and Drug Administration (FDA) recently adapted certain searches and information to highlight regulatory guidance for specific medical device types.
Japan Regulatory Requirements – Medical Device Software
In this on-demand webinar, our Emergo by UL subject matter expert shares insights on Japanese regulatory requirements for medical device software.
Optimizing a QMS for Medical Device Companies
In this on-demand webinar, our Emergo by UL subject matter expert shares insights on how to optimize a QMS for global medical device companies.
Due Diligence Services for Mergers and Acquisitions
Our due diligence services help medical device companies navigate complex regulatory requirements to avoid post-transaction complications.
Regulatory Analysis for Medical Device Mergers and Acquisitions
We will analyze the regulatory impact of the envisioned merger or acquisition and outline a regulatory roadmap by country for prioritization.
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.
Overview of India’s Medical Device Regulatory Framework
Learn more about India CDSCO medical device regsistration and approval requirements.
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.