Medical Devices and IVDs

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

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

Internal Audits

We conduct internal audits to evaluate QMS effectiveness and identify areas for improvement.
Our audits are tailored to specific needs and risks, addressing critical processes and procedures.
We provide comprehensive audit reports with findings, recommendations, and corrective action plans.

Lead Auditor Support

We train and mentor internal staff to become qualified lead auditors.
We provide on-site support during internal audits, offering guidance and expertise.
This increases audit efficiency and builds the team's internal capabilities.

Process and Procedure Validation

We validate critical processes to ensure they consistently meet quality requirements.
We use recognized methodologies and provide documented evidence for validation.
This demonstrates regulatory compliance and ensures process reliability.

Document Compiling and Writing

We assist in compiling and writing documentation for ISO 13485 and ISO 9001 certifications.
Our team has extensive experience in medical device standards ensuring accuracy and compliance.
We provide ongoing support to update documentation as the QMS evolves.