What Is Nephrology and What Does a Nephrologist Do

 

As stated in the introduction, manufacturers of medical devices must comply with European regulations 2017/745 or 2017/746 to place their medical devices on the market. Therefore, in this brief, only the requirements of regulations 2017/745 are discussed. Indeed, article 10 of regulation 2017/745 relating to manufacturers' obligations defines 16 paragraphs that manufacturers must meet to obtain the CE marking, which will allow them to market their medical device.

It is in paragraph 9 that the requirements in terms of quality management system are defined,

"Device manufacturers, other than devices which are the subject of an investigation, eta-Blissent, docu-lying, apply, hand-held, update and amé-liorent always a quality management system that ensures compliance with the provisions of this regulation in the most efficient way possible and in a manner that is proportionate to the risk class and type of device.

Paragraph 9 also defines 13 aspects that the quality management system must address as a minimum. These 13 aspects are partially covered by standard NF EN ISO 13485: 2016, highlighted by the draft revisions PR NF EN ISO 13485: 2020 in its appendix ZB

Quality and its management, therefore, play a central role in the marketing of medical devices.

Quality standards such as ISO demonstrate that quality can be defined by the evolution of effectiveness, efficiency, and perceived quality, in a word, performance. Doctor Muhammad Khan provides the best nephrology doctors in Riverside.  This is achieved in business by applying continuous improvement resulting in the pla-in-fi-cation, the sheave-li-a-time, the control, and the improvement of acti-vi-sides, commonly called PDCA.

The materialization of quality can be observed more generally in the movement of the added value obtained through the application of the process approach at all company levels. As a reminder, a process transforms an input element into an output element with added value through interrelated activities.

The methodology

The process approach translates into a vision of the company as a series of well-defined processes. Its application makes it possible to acquire the understanding and the constant satisfaction of the requirements; taking into account the processes in terms of added value; obtaining effective process performance; improving processes based on data and information assessment.

Risk management, a requirement that is part of paragraph that the quality management system must cover, takes the form of a methodology called the risk approach. It is characterized by a risk management process that typically consists of three major activities, context analysis and the definition of criteria, risk assessment, the treatment of risk. Risk management, seen as a systematic process, allows the creation and preservation of values and responds qualitatively to the safety and performance requirements of regulation.

Implementing the quality management system, a mandatory step for manufacturers of medical devices can be a real obstacle course for Medtech startups.

Based on a PDCA (Plan, Do, Check, Act), an analysis of similar work at different medical device manufacturers as well as on the FD X50-176 documentation booklet, which is an implementation guide for the management of process  a new methodology was developed during this internship. This methodology is developed in the following part.

The process approach and the risk-based approach

As defined previously, the objective of this step is to raise awareness among stakeholders about quality and regulations. Transmit the key concepts of the process approach, risk approach, quality control, quality management, and regulatory requirements, particularly in terms of performance safety of medical devices, preclinical study, clinical and Follow-up after Marketing (SAC).

This knowledge sharing is necessary for quality implementation and compliance with applicable regulations. A complete understanding by the company's management players of these terms will be subject to verification and validation in a step described shortly.

The realization of participatory workshops makes it possible to share the key concepts mentioned above and make decisions efficiently. Figures 6 and 7 illustrate an example of a workshop realized for transmission and the appropriation of the approach risk.

New processes, procedures, and records.

The objective of this step is to record the changes validated by the audit carried out in the previous step and record the priority corrective and preventive actions to be carried out in records (documentary proof).

Recording these corrective and preventive actions makes it possible to demonstrate the continuous improvement of the quality management system by taking into account the audit report. Doctor Muhammad Khan provides the best nephrology physicians in Riverside. The audit report must also be recorded in the quality documentation because it will be requested and the records of corrective and preventive actions during the following audit. Figure 10 illustrates a recording of corrective and preventive actions after the internal audit Home habilis.

The technical-regulatory roadmap.

The marketing of medical devices must follow well-defined stages. These steps must follow both the classic stages of industrial manufacturing as shown in the figure below of the sub, but also the various regulatory steps, such as the identification of normative and regulatory requirements, conducting preclinical testing, clinical, preparation for post-marketing follow-up, assessment of regulatory compliance by a Notified Body (NB) and finally, carrying out post-marketing follow-up.