Clinical Evaluation and Performance Evaluation in Medical Device Regulation A Comprehensive Overview of International Standards and Japanese Regulatory Requirements Introduction […]
FDA Medical Device Quality System Regulation (QSR) Amendment: Current Status and Industry Impact Background and Initial Amendment Announcement In 2018,
Design Transfer: Definition, Requirements, and Implementation Regulatory Background ISO 13485:2016 explicitly incorporates “Design and Development Transfer” as a mandatory requirement.
Clinical Evaluation and Performance Evaluation ISO 13485 Section 7.3.7, “Design and Development Validation,” specifies the following requirements: “As part of
Data Integrity in Pharmaceutical and Medical Device Manufacturing Introduction Does the data integrity requirement apply to medical device companies as
The Latest Timeline and Implementation Status of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) Overview of
On Usability Introduction When hearing the term “usability,” one might imagine “ease of use.” However, usability in the context of
MDR Vigilance System: Building Comprehensive Post-Market Surveillance for Medical Devices Historical Background: From MDD to MDR The transition from the
Differences Between Pharmaceutical and Medical Device Regulations Regarding Engineering Design In recent years, pharmaceutical companies have increasingly expanded into the
Document and Record Management in Regulated Industries ISO 13485:2016 explicitly states that records are a type of document. However, in
