Conduct clinical evaluations to assess the safety and performance of your medical device

Risk Management

Initiate the certification process with a thorough risk management assessment of your medical device. Identify potential hazards and assess risks to patient safety, ensuring mitigation strategies are in place to address any potential issues.

Regulatory Compliance

Navigate the complex landscape of medical device regulations and standards. Ensure compliance with regulations such as ISO 13485 for quality management systems and FDA regulations for medical devices marketed in the United States.

Design Validation

Conduct rigorous validation testing to ensure the safety and effectiveness of your medical device. Perform tests to validate design specifications, functionality, and performance under various conditions, ensuring it meets the intended use requirements.

Clinical Evaluation

If required, conduct clinical evaluations to assess the safety and performance of your medical device in real-world clinical settings. Collect and analyze clinical data to demonstrate the device’s safety and efficacy for its intended use.

Usability Testing

Evaluate the usability of your medical device through usability testing. Assess factors such as user interface design, instructions for use, and ergonomic considerations to ensure ease of use and minimize the risk of user errors that could impact patient safety.

Quality Management Systems

Implement and maintain robust quality management systems (QMS) to ensure the consistent quality and safety of your medical device throughout its lifecycle. Adhere to ISO 13485 requirements for QMS to demonstrate compliance with international quality standards.

Post-Market Surveillance

Establish mechanisms for post-market surveillance to monitor the safety and performance of your medical device after it has been placed on the market. Implement processes for adverse event reporting, complaint handling, and corrective and preventive actions to address any safety concerns that may arise.

Establish mechanisms for post-market surveillance to monitor the safety and performance of your medical device after it has been placed on the market. Implement processes for adverse event reporting, complaint handling, and corrective and preventive actions to address any safety concerns that may arise.