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Medical Device Quality Assurance

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Medical Device Quality Assurance

Medical Device 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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