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Medical Device & IVDs

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Medical Device & IVDs

Empowering Healthcare Through Innovation

Medical devices are essential tools used in modern healthcare for various purposes, including diagnosis, prevention, monitoring, treatment, and symptom alleviation. They range from simple instruments like tongue depressors and bandages to complex machines like pacemakers and artificial limbs. In vitro diagnostic (IVDs) medical devices are a type of medical device that examines samples taken outside the living body, such as blood, tissue, or other fluids, to determine a person’s health. Examples of IVDs include pregnancy tests, blood sugar tests, cholesterol tests, tissue biopsies, and genetic tests.

OMC Services

Empowering Healthcare Through Innovation

Medical devices are essential tools used in modern healthcare for various purposes, including diagnosis, prevention, monitoring, treatment, and symptom alleviation. They range from simple instruments like tongue depressors and bandages to complex machines like pacemakers and artificial limbs. In vitro diagnostics (IVDs) are a type of medical device that examines samples taken outside the living body, such as blood, tissue, or other fluids, to determine a person’s health. Examples of IVDs include pregnancy tests, blood sugar tests, cholesterol tests, tissue biopsies, and genetic tests.

 

Medical devices are essential tools used in modern healthcare for various purposes, including diagnosis, prevention, monitoring, treatment, and symptom alleviation. They range from simple instruments like tongue depressors and bandages to complex machines like pacemakers and artificial limbs. In vitro diagnostics (IVDs) are a type of medical device that examines samples taken outside the living body, such as blood, tissue, or other fluids, to determine a person’s health. Examples of IVDs include pregnancy tests, blood sugar tests, cholesterol tests, tissue biopsies, and genetic tests.

 

Regulatory Compliance

Regulations for both medical device & IVDs ensure their safety and effectiveness, typically involving pre-market approval and post-market surveillance. These regulations vary depending on the country but typically involve pre-market approval and post-market surveillance. 

The importance of medical devices and IVDs lies in their ability to enable earlier and more accurate diagnosis, improved disease monitoring, development of new treatments, and improved quality of life for patients. 

The field of medical devices and IVDs is constantly evolving, with new technologies emerging to further improve healthcare and patient outcomes. As new technologies emerge, the promise of further improvements in healthcare and patient outcomes is immense. 

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

OMC Services

Medical Devices and IVDs

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