MEDICAL DEVICE FILE
Asha Meria J.
Medical Devices Regulatory Affairs Professional: RCC - MDR (RAPS) | Biomedical Engineer | MedTech Consultant - Striving to Improve the Lives of Patients and Healthcare Professionals 🙏
As per Cl. 4.2.3 of ISO 13485, the MEDICAL DEVICE FILE includes everything the manufacturer needs to prove that the medical device has achieved its conformity to ISO 13485 and compliance with applicable regulatory requirements and is ready for the manufacturing process. Besides that, it is used as the communication gateway between the product development team, and the manufacturing operations team, such as production, quality assurance, quality control, purchasing and warehouse.
The medical device file shall include the following information (not limited to):
#1. General description of the medical device, intended use/purpose, and labelling including any instructions for use;
#2. Product specifications;
#3. Specifications or procedures for manufacturing, packaging, storage, handling and distribution;
#4. Procedures for measuring and monitoring;
#5. Installation requirement, if applicable
#6. Servicing requirements for the medical device that requires attention during certain periods of usage such as calibration, change of spare parts, etc., if applicable.
Therefore, as a medical device manufacturer, you are expected to maintain a medical device file for each device type or family that pertains to your business.
For enquiries, please email me at aj@i3cglobal.com