№ lp_1_2_51458
The document outlines regulatory pathways and considerations for personalized medical devices (PMDs), addressing new manufacturing technologies like additive and subtractive methods and point-of-care manufacturing.
Year: 2022
Region / City: Global
Topic: Medical Devices, Regulatory Frameworks
Document Type: Regulatory Guidance
Organization / Institution: International Medical Device Regulators Forum (IMDRF)
Author: IMDRF Personalized Medical Devices Authoring Group
Target Audience: Medical Device Regulators, Manufacturers, Healthcare Professionals
Period of Validity: N/A
Approval Date: 10 August 2022
Date of Changes: N/A
Price: 8 / 10 USD
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