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IVD Medical Devices


Service Providing: recruitment, human resources, training, regulatory compliance, quality management systems, product development and licensing, ISO certification, CE certification, and plant setup.

In vitro diagnostic (IVD) medical device services are specialized services that revolve around the development, manufacturing, regulatory compliance, and support of IVD medical devices. IVD devices are used for diagnostic testing of samples taken from the human body, such as blood, urine, or tissue, outside of the body. These tests are critical for diagnosing diseases, monitoring health conditions, and guiding treatment decisions. Here are some key aspects of IVD medical device services:

  1. Regulatory Compliance: Ensuring that IVD medical devices comply with the regulatory requirements of the region where they will be marketed. This often includes adhering to standards such as the In Vitro Diagnostic Regulation (IVDR) in Europe or the U.S. FDA's regulations for IVDs.

  2. Product Development: Assisting in the research, development, and design of IVD devices. This includes feasibility studies, prototype development, and optimization of assay methods.

  3. Clinical Trials: Designing and conducting clinical trials to evaluate the performance, safety, and effectiveness of IVD devices. This can involve patient recruitment, data collection, and statistical analysis.

  4. Quality Management Systems (QMS): Establishing and maintaining QMS in accordance with standards like ISO 13485 to ensure the quality and consistency of IVD device manufacturing.

  5. Manufacturing Support: Providing guidance on the manufacturing processes of IVD devices to ensure they meet quality and regulatory standards. This includes validation of manufacturing processes.

  6. Technical Support: Offering technical support and training to laboratory professionals and healthcare providers on the proper use and maintenance of IVD devices.

  7. Documentation and Regulatory Submissions: Preparing and submitting regulatory documentation required for device approvals, such as technical files, design dossiers, and pre-market notifications.

  8. Post-Market Surveillance: Monitoring the performance and safety of IVD devices once they are on the market, including the collection and analysis of adverse event data.

  9. Labeling and Packaging Compliance: Ensuring that labeling and packaging of IVD devices meet regulatory requirements and convey accurate information to users.

  10. Distribution and Supply Chain Management: Managing the distribution, storage, and supply chain logistics for IVD devices to ensure they reach healthcare facilities in a timely and efficient manner.

  11. Recall Management: Developing procedures for handling recalls in the event of defective or unsafe IVD devices and coordinating recall efforts.

  12. Consulting and Advisory Services: Providing expert guidance on regulatory strategy, reimbursement strategies, market analysis, and other aspects of the IVD industry.

Case Study

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The Problem

  • Developemnt on Procedures, Product specification, Product technical Documents.

  • Defined the processes and their interrelation.

  • Preparation and implementation of each procedure for processess and equiments. 

Our Solutions

Preparation, approval and implementation of the procedure of quality management system which fulfills the requirements of regulatory, CE and ISO standards.

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