Supplier Management

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 At  Dexter Advisors, we understand that the quality and reliability of your suppliers play a crucial role in the success of your medical devices. Our Supplier Management services are designed to help you build and maintain a robust supply chain that meets the highest standards of quality, compliance, and efficiency.

Our comprehensive Supplier Management services cover all aspects of the supplier relationship, ensuring that your partners align with your business goals and regulatory requirements. We offer:

• Supplier Qualification: We conduct thorough assessments to ensure potential suppliers meet your quality, compliance, and performance standards before they become part of your supply chain. This includes reviewing supplier capabilities, capacity, and past performance.
• Auditing and Monitoring: Regular audits and performance monitoring help maintain high standards and address any issues promptly. We ensure suppliers comply with industry regulations & standards such as EU MDR , FDA and ISO 13485. This includes on-site audits, remote audits, and periodic reviews. 
• Risk Management: We identify and mitigate risks within your supply chain, implementing strategies to prevent disruptions and ensure a steady flow of quality materials and components. This includes conducting risk assessments and establishing mitigation plans.
• Supplier Development: We work closely with your suppliers to enhance their capabilities, ensuring they can meet your evolving needs and contribute to your business's success. This includes providing training, technical support, and continuous improvement initiatives.
• Quality Agreements: We establish clear and comprehensive quality agreements with your suppliers, outlining expectations, responsibilities, and compliance requirements to ensure product quality and regulatory adherence. These agreements cover quality standards, testing protocols, responsibility matrix and communication processes.
• Supplier Evaluation: We perform detailed evaluations of supplier performance, using metrics and key performance indicators (KPIs) to assess quality, delivery, and compliance. This ongoing evaluation process helps in making informed decisions about supplier partnerships.
• Non-Conformities Management: Prompt and effective resolution of any supplier-related non-conformities, ensuring minimal impact on your operations and product quality. We work with suppliers to identify root causes and implement corrective actions to prevent recurrence.
• Creating and Maintaining the Approved Supplier List (ASL): We develop and manage an Approved Supplier List to ensure that only qualified and vetted suppliers are part of your supply chain. This process helps maintain high standards of quality and compliance and provides a reliable resource for sourcing materials and components.
• Supplier Performance Review: Conduct regular performance reviews with suppliers to discuss their performance, address issues, and set improvement goals. This includes reviewing audit findings, quality metrics, and delivery performance.
• Change Control Management: Ensure that any changes in the supplier’s processes, materials, or locations are properly managed and communicated. This includes evaluating the impact of changes on product quality and compliance.
• Documentation and Traceability: Maintain comprehensive records of all supplier-related activities, including audits, qualifications, evaluations, and communications. Ensure traceability of materials and components from suppliers to finished products.