Europe
The Medical Device Coordination Group (MDCG), the advisory body that consults the European Commission on the implementation of laws surrounding medical device circulation, issued guidance related to a new codification system to be used under the framework established...
Uncategorized
The International Medical Device Regulators Forum (IMDRF) has released guidelines on clinical evaluations, clinical investigations, and clinical evidence for medical devices. These documents replaced the previous documents that regulated the same areas as issued by...
North America
The FDA, the regulating authority in the sphere of medical device circulation of the United States, issued guidance providing additional information on new pilot conformity assessment procedures. ASCA: key points The Accreditation Scheme for Conformity Assessment...
Uncategorized
What Is It? ISO 13485 is a quality management system that is used internationally. It controls safety in work environments, risk management, and design, and creates requirements for inspections, documents, procedures, and verification of safety and effectiveness of...
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