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Medical Device Quality Assurance

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Medical Device Quality Assurance

Quality Assurance

At OMC Medical, we understand the critical role of quality assurance in ensuring the safety and efficacy of medical devices. That’s why we offer a comprehensive suite of services to help you establish, maintain, and improve your quality management system (QMS).

Supplier Audits

  • 1. We conduct pre-qualification audits to assess a supplier's ability to meet the quality requirements before awarding contracts.
  • 2. We perform ongoing supplier audits to ensure they continue to comply with the specifications and regulatory standards.
  • 3. Our audits cover all aspects of the supplier's QMS, including quality control, documentation, and recordkeeping.

Internal Audits:

  • 1. We conduct internal audits to evaluate the effectiveness of the existing QMS and identify areas for improvement.
  • 2. Our audits are tailored to the specific needs and risks, ensuring they address the critical processes and procedures..
  • 3. We provide comprehensive audit reports with detailed findings, recommendations, and corrective action plans.

Lead Auditor Support

  • 1. We can train and mentor the internal staff to become qualified lead auditors, empowering them to conduct internal audits independently.
  • 2. We offer on-site support during the internal audits, providing guidance and expertise.
  • 3.This increases the audit efficiency and effectiveness, while building the team's internal capabilities.

Process and Procedure Validation

  • 1. We assist in validating the critical processes and procedures to ensure they consistently meet the quality requirements.
  • 2. We use recognized validation methodologies and provide documented evidence to support the validation activities.
  • 3. This helps the demonstrate compliance with regulatory requirements and ensure the reliability of the processes.

Document Compiling and Writing

  • 1. We assist in compiling and writing the necessary documentation for obtaining ISO 13485 and ISO 9001 certifications.
  • 2. Our team has extensive experience in medical device regulations and standards, ensuring the documentation is accurate, complete, and compliant.
  • 3.We also offer ongoing support to maintain and update the documentation as the QMS evolves.

Gap Analysis

  • 1. We conduct gap analyses to assess the compliance of the existing quality system with relevant standards and regulations.
  • 2. We identify areas where the system needs improvement to achieve certification or maintain compliance.
  • 3. This helps to prioritize the corrective actions and develop a clear roadmap for improvement.

Beyond these specific services, we also offer

  • 1. Expert advice and guidance on regulatory compliance and best practices.
  • 2. Ongoing support to maintain and improve the QMS over time

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