Med'In QARA - Quality Management
Development and management of your Quality Management System (QMS)
Implementing a Quality Management System (QMS) is a strategic approach that ensures your operations and medical devices comply with the most stringent standards, such asISO 13485 or the MDSAP program, and regulations such as European Regulation 2017/745 (EMDR) and QSR 21 CFR Part 820 in the United States.
My approach is to tailor each stage of the QMS implementation to your specific needs, taking into account the particularities of your company, your products and your target markets.
Setting up your QMS in 7 steps :
Initial Assessment and Gap Analysis
Definition of Key Processes and their Documentation
Integration of Risk Management Tools
Implementation of QMS Documentation
Team training and involvement
Implementation of Performance Indicators
Preparing for internal and external audits
Benefits of a QMS that complies with applicable standards :
By structuring your QMS in line with the requirements of applicable standards, you not only reinforce the quality and conformity of your medical devices, and the reliability of your processes, but also ensure your company's resilience in the face of audits and inspections. By working with Med'In QARA, you benefit from personalized support to make your QMS a real competitive advantage on the global market.
Optimize Your QMS with Med'In QARA for Responsive and Efficient Processes
A high-performance Quality Management System (QMS) is the key to guaranteeing the conformity and quality of your medical devices. Med'In QARA supports you in optimizing and managing your QMS, by combining the requirements of recognized standards with industry best practices, so that your system becomes a genuine performance driver.
My Quality Management Services :
Evaluating and optimizing your QMS
Setting up efficient processes
CAPA support
Benefits of an Optimized QMS :
With a solid, optimized QMS that complies with the requirements of applicable standards (ISO 13485, 21 CFR part 820, MDSAP, EMDR 2017/745...), you can guarantee the high quality of your medical devices while increasing the efficiency of your internal processes. This translates into reduced costs linked to non-conformities, better risk control, and increased customer satisfaction. By working with Med'In QARA, you benefit from personalized support to make your QMS a competitive advantage for your company.
My audit services for medical devices
Customized audits to ensure regulatory compliance
As a former audit manager for a notified body and a pre-certified ICA ISO 13485 auditor, I know that audits are essential for assessing and reinforcing the compliance of your processes and products with current standards. By working with Med'In QARA, you can rest assured of our in-depth expertise in meeting the requirements of regulatory bodies and guaranteeing the safety of your medical devices.
Proposed audits :
- Site preparation audit: I support your teams in preparing for regulatory inspections and audits (ISO, CE marking, ANSM, FDA, etc.). This service covers all the stages required to guarantee full compliance with the expectations of the health authorities, ensuring that each stage of the audit is managed rigorously and efficiently.
- Supplier and subcontractor audits: Controlling the quality of your suppliers and subcontractors is essential to guarantee the reliability of your medical devices. On your behalf, I carry out a thorough assessment of the conformity of your outsourced processes with your manufacturing subcontractors and testing laboratories.
- Internal audit : Internal auditing is a key step in identifying areas for improvement and reinforcing the quality of your operations. I ensure the robustness of your internal processes, laboratories, procedures and design files, by carrying out your internal audits.
- Pre-acquisition audit: If you are considering acquiring a site or infrastructure, Med'In QARA offers rigorous audits to ensure that the acquisition complies with the regulatory and standards requirements applicable to you.
Key benefits
By calling on my auditing services, you can ensure your company's compliance, while guaranteeing the quality and safety of your medical devices. I help you anticipate inspections, reducing the risk of non-compliance and business interruption. With Med'In QARA, you benefit from support that reinforces the confidence of your partners and regulatory authorities.
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