QUALITY ASSURANCE FOR MEDICAL DEVICES AND IVDs
ISO 13485 FOR MEDICAL DEVICES
Quality and Regulatory requirements in the Medical Device industry can be challenging for the organisations. IVDEXEL is the best partner to help you with a Quality strategy to align the the processes of your Quality Management System.
How can IVDEXEL assist your organization?
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Implementation of the QMS
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Implement the Risk management System (RMS)
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Gap analysis for QA/RA
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Internal Audit programs
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Management Review
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Avoid major NC
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Selection of appropriate technical standards for your industry and products.
ISO 14971 FOR RISK MANAGEMENT
The experience showed that a high percentage of Manufacturers do not apply the Risk Management System to meet the requirements of the ISO 14971. IVDEXEL will help you understand the impact of ISO 14971:2019 on the decision-making processes when manufacturing Medical Devices.
IVDEXEL will help you:
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Identify the key requirements of ISO 14971:2019.
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Support with your Risk Management Policy.
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How to communicate the key requirements and expectations of ISO 14971:2019 to your organization.
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Gain knowledge on how ISO 14971:2019 links to ISO 13485 and the regulations.
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Apply the fundamental risk management activities for Medical Devices within your organization.
ISO/TR 20416 FOR POST-MARKET SURVEILLANCE
How can IVDEXEL help you:
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How to integrate the PMS and vigilance processes into the QMS and product life-cycle.
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How to understand the main concepts and requirements of the post post-market surveillance and vigilance.
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How to communicate the impact of key requirements in your organization.
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To use essential tools to implement a compliant post-market surveillance and vigilance for different jurisdictions.