The medical device validation and performance is important from the market point of view since a validated product is complying with the safety specifications proposed by international and national regulations simultaneously meeting the requirements of the different regulations for commercialization. Complying with these requirements implies that the product can be commercialized generating profits for designers, producers, and transformers of medical devices.
From biomedical engineering, it is intended to associate the term validation with understandable concepts that allow a definition of it from applied engineering research. The requirements demanded by international regulations were linked through standards such as ISO 13485: 2003, with solutions proposed from engineering.
Medical Device Validation Levels
It is concluded that the medical device validation should be developed at two levels: the pre-market evaluation; where activities should be carried out to evaluate economic viability, technical viability, ethical and legal viability, the study of epidemiological risk factors and clinical product trials; and a post-market evaluation; where evaluation activities must be carried out on the traceability of the process (internal and external audit), post-market economic viability and product sustainability over time.
This will allow obtaining scientifically based evidence to make appropriate decisions when designing, manufacturing, and transforming materials into medical devices with a high degree of quality.
The selection of materials plays a important role in the evaluating the biological safety. The material selection and risk analysis are considered as integral components of the design
process for medical devices. As per ISO 14971, risk management activities must be planned in advance. The biological evaluation is considered as a part of risk management activity and hence it is required to evaluate the biological safety of the medical device, considering the intended application of device, during the design and development process. And also the manufacturer should evaluate the biological safety of a medical device over the whole life-cycle.
Biocompatibility testing of materials is considered as a part of verification and the clinical evaluation or performance evaluation of the medical device considered as a part of validation, during the design and development process.
The aim of Biological Evaluation of medical devices as per ISO 10993-1 is to protect humans from potential biological hazards such as genotoxicity, carcinogenicity, haemotoxicity, etc., arising from device-tissue interaction. Therefore, it is mandatory to evaluate the biological safety of a medical device by a manufacturer prior to its launch, mainly to understand and mitigate such biological hazards due to the device.
No, it is not a part of the design validation. The ISO 10993-1:2018 clearly states in its introduction that Biological Evaluation is part of the “design verification”, which is set in the context of risk management processes conducted according to the requirements of ISO 14971.