Med'In QARA - Quality Management

The first step is to define the applicable standards and compare your practices with the requirements of these standards.

This diagnosis (Gap analysis) enables you to target compliance gaps and define priorities for building a complete and compliant QMS. This stage is essential for structuring the implementation of your QMS and guaranteeing a rigorous approach.

Once the requirements have been identified, the key QMS processes are defined, such as risk management, supplier management, and design and development control.

Processes are defined by combining a SWOT analysis with a risk-based approach. Processes are documented and structured to meet normative requirements, facilitating traceability and implementation.

In line with ISO 13485, risk management according to ISO 14971 standard is integrated into the realization and surveillance processes, to identify and mitigate potential risks from the design phase through to use, taking into account the production and marketing of your devices.

Depending on your needs, I can help you develop this process and the associated documentation. 

Quality documentation is a cornerstone of your QMS. I can help you create these key documents, including :

The maintenance and effectiveness of a QMS depends largely on the training and involvement of all personnel. 

I organize operational training dedicated to your quality system. These courses enable your teams to familiarize themselves with the applicable standards and regulatory requirements through the quality documentation in place, and to comply with them in their day-to-day practices. In this way, everyone becomes aware of their role and its impact on the efficiency of the QMS and the safety of the devices.

An effective QMS is based on Quality Objectives and Performance Indicators (KPIs) defined with top management. Monitoring KPIs and compliance with objectives enables us to continuously track the efficiency of our processes. Together, we define these indicators (e.g. non-conformity monitoring, customer satisfaction, CAPA processing times, etc.), which will be your levers for adjusting and optimizing your QMS.

To ensure ongoing compliance of your QMS, I support your team in preparing for internal and external audits, ensuring that every requirement of the applicable standards is met. This support includes checking documents, simulating audits, and implementing corrective measures where necessary.