Author name: ecompliance

From CSV to CSA: A New Era in Computer System Assurance FDA’s New Guidance Framework The FDA’s Center for Devices […]

The Importance of Clinical Evaluation in Medical Device Development Regulatory Requirements ISO 13485:2016, clause 7.3.7 (Design and Development Validation), establishes

Misuse and Use Error: Usability Engineering in Medical Device Design Positioning Misuse in Regulatory Requirements ISO/IEC Guide 51:2014 “Safety aspects

Public Comments Solicitation on the Proposed Ordinance Amending the Ordinance Regarding Standards for Manufacture Control and Quality Control of Medical

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