An overview of MEDDEV 2.7.1 Rev. 4, the latest clinical evaluation guidance released by European Commission
An overview of usability engineering and its impact on legacy medical devices
Establishing a unique complaint handling process to improve user safety, regulatory compliance and customer satisfaction
An overview of Test Method Validation Regulations and effective methods of implementing them
A Design History File (DHF) is a compilation of documentation that describes the design history of a finished medical device. The Design History File encompasses the objective evidence that the design has been developed in accordance with the Design and Development Plan, in compliance with regulatory requirements and design control requirements.
The new and stringent requirements related to clinical evidence has already created chaos among the industry. It necessitates the manufacturer to go through the existing evidence and ensure that it is in compliance with the new definitions and performance evaluation requirements set by IVDR.
The latest change in the European Medical Device Regulations is going to affect the operation of different entities ranging from economic operators, manufacturers, service providers, competent authorities, and European Institutions. The changes are seen with a positive intent by the Medical Device Industry and it is believed that the changes will open new doors for innovation and safer development of medical Devices.