How to ensure the Validation of a Medical Device
Unlike the Validation of a laboratory or production equipment or even a software, for a medical device it is not enough to simply create a qualification file. You have to know your medical device. You need a file that would follow the famous V-cycle and would contain the user requirements, the functional requirements, the risk analysis, the validation plan and the protocols and reports of Installation Qualification, Operational Qualification, Performance Qualification among others.
First of all, everything is based on the classification of the medical device in question: I (and special I), IIa, IIb or III, which changes a lot!
The validation of a medical device is an integral part of what is called the Design History File, i.e. the file that encompasses all the documentation of a medical device from the feasibility studies through its development, to the verification, validation and transfer to production activities.
Once the “Design and Development Planning”, “Design Input” and “Design Output” phases have been completed and validated, the project team for the development of the new medical device begins the “Design Verification” phase, which is followed by the “Design Validation” phase.
These two phases can be related to what is classically known as Qualification / Validation, i.e. for equipment, software, processes etc. However, in the context of medical devices, we go beyond the sole verification of the proper functioning of the product, by verifying and validating all aspects related to the medical device being developed.
The regulations and in particular the new MDR regulations require several points in the context of the verification and validation of the medical device, of course some points are to be modulated according to the type and class of the medical device. ISO standards guide us in these different actions.
Let’s take a look at these different points to ensure proper verification and validation!
- Verify the biocompatibility of the medical device (except if the medical device is software only) via test protocols and reports on the characterization of the different materials used in the design of the medical device and via biocompatibility studies (nature and duration of contact between the different materials and the human body or a substance which will then be in contact with the human body). We can refer to the ISO 10993 standard series.
- Check the electrical safety and electromagnetic compatibility, if it is an electro-medical device. It is verified that the electro-medical device does not induce, in particular, any unacceptable electrical risk in normal conditions of use or in first fault condition, the test conditions are the least favorable configuration for the product. For the verse on electromagnetic compatibility, it is a question of verifying the immunity of the device to electromagnetic radiation but also verifying its electromagnetic emissions in order to limit disturbances in relation to other medical equipment and devices present in the same environment. We can refer to the ISO 60601-1 and 60601-1-2 standards.
- Verify the software if the medical device is software or has embedded software. Depending on the safety class of the software defined by the IEC 62304 standard (A, B or C), the software verification effort and the type of tests required will not be the same. The verification will demonstrate that the software works and meets the requirements issued (software system verification), in addition, for classes B and C, unit verification and integration verification tests will be required.
- Checking the shelf life in its packaging (and thus its stability) before use are also points to be verified within the framework of the Validation for medical devices.
- Verify the overall design (including the instructions for use and labels) of the medical device, whether it meets the stated needs and requirements, whether its performance is as expected, … Also verify the claimed lifetime of the medical device and validate its suitability for use in order to prevent hazards related to possible misuse.
- Validate the packaging chosen and the transport conditions, particularly for sterile medical devices where the integrity of the sterile barrier must be preserved.
- Validate the sterilization of the medical device (if necessary) and the methods used to ensure its complete sterilization. Detailed methods for the end user to clean and/or disinfect the medical device must also be validated to prove their effectiveness.
- Check the MRI compatibility of the medical device if during its life it may be in contact with or in close proximity to an MRI.