When discussing product quality, organisational quality cannot be ignored. In a total approach, quality extends to the entire company system, is the reference and objective for any activity and involves not only the quality division but all personnel, including every process and procedure, internal and external to the organisation, for the entire life cycle of the medical device. Thus, product quality is a direct consequence of organisational quality.
Medical Device manufacturers can foster the growth of a quality culture in their environment by improving all processes and establishing an accurate and comprehensive control mechanism.
To do this, one must first understand the basic principles, starting with the Medical Device Regulation MDR (EU) 2017/745, which stipulates the mandatory implementation of a Quality Management System (QMS).
A further key reference is ISO 13485:2016, an internationally recognised harmonised standard intended for use by any organisation involved in the design, development, manufacture, installation and servicing of Medical Devices or related services.
Device Safety
The concept of product quality inevitably recalls that of safety. How can the manufacturer market a quality device with evidence that its product does not endanger the patient or the user?
In response, it is necessary to think of safety as a management and, therefore, system requirement, considering the incident no longer as the consequence of a single human error, but as the effect of an interaction between technical, usability, organisational and process factors.
In addition, manufacturers must design Medical Devices aiming at minimising operating errors and consequent damage, focusing in particular on the user interface.
ISO 14971:2022, accompanied by ISO/TR 24971, is the practical application guide to the standard that provides a framework for risk management of Medical Devices; the process described is intended to assist manufacturers in identifying hazards associated with Medical Devices, assessing and controlling risks, and monitoring the effectiveness of the process. The requirements apply throughout the life cycle of the medical device
Device Clinical Evaluation
In the clinical evaluation process, the manufacturer must demonstrate that its device is capable of achieving the expected performance during normal conditions of use and that known and foreseeable risks, together with any adverse events, are reduced to an acceptable minimum concerning the benefits of the expected performance.
Within the design process there must be evidence of the processes of:
- Preclinical evaluation;
- Risk management;
- Any necessary clinical investigations;
- Clinical evaluation;
- Tests to validate the intended use of the device, performed under real or simulated conditions;
- Post-market clinical follow-up plan.
Quality in the Design Phase
To reduce losses, costs and image damage due to medical device failures, and to fulfil contractual obligations with customers, manufacturers must pay close attention to quality management, and adopt best practices, which improve the speed and efficiency of the design process.
In addition, new technologies are a valuable aid in developing products with ever higher quality, effectiveness, performance and safety for the patient’s health.
Conclusions
In conclusion, the design of a device cannot disregard the technology with which it is manufactured, the safety and performance specifications, the regulatory requirements and the organisation’s processes.
In a modern and successful vision of product development, the Project Leader brings processes to interact with each other and proceed in parallel for effective and optimised design.
For expert support in implementing Quality Management System (QMS) requirements, contact us at sales@thema-med.com.
