Validation and Verification

Validation and Verification

Protheragen-ING Lab understands the critical importance of validation and verification in the development and manufacturing of medical devices. we specialize in providing comprehensive validation and verification services for medical devices.

We understand the criticality of ensuring the safety, effectiveness, and compliance of medical devices before they are brought to market. Our team of experts has extensive experience in the medical device industry and can assist you throughout the entire validation and verification process, helping you achieve regulatory compliance and peace of mind.

Fig.1 Validation and Verification

The available services of Protheragen-ING Lab are as follows:

Design Validation and Verification

Design validation and verification are crucial steps in the development of medical devices. Our team can support you in assessing the design of your medical device to ensure it meets the intended use and user needs. We utilize a range of techniques, including thorough analysis, simulations, and testing, to verify that the design meets all relevant regulatory requirements and standards. Our design validation and verification services include:

  • Requirement analysis and traceability.
  • Usability testing and human factors engineering.
  • Risk assessment and mitigation strategies.
  • Performance testing and analysis.
  • Design verification documentation.

Process Validation and Verification

Manufacturing process validation and verification are essential to ensure consistent and reliable production of medical devices. Our team can assist you in validating and verifying your manufacturing processes, ensuring that they meet the required quality standards and regulatory guidelines. Our process validation and verification services include:

  • Development and execution of validation protocols.
  • Statistical analysis of process data.
  • Identification and control of critical process parameters.
  • Process monitoring and control strategies.
  • Establishment of process validation documentation.

Other supplementary Services

In addition to design and process validation and verification, we offer a range of supplementary services to support your medical device development and compliance efforts. These include:

  • Risk management: We can help you identify, assess, and mitigate risks associated with your medical device throughout its lifecycle. Our experts can assist in developing risk management plans, conducting risk assessments, and implementing risk control measures.
  • Quality management system (QMS) support: We can provide guidance in implementing and improving your QMS, ensuring compliance with relevant quality standards such as ISO 13485. Our services include QMS gap assessments, documentation development, and training.
  • Regulatory compliance support: Our team is well-versed in regulatory requirements and can assist you in navigating the complex landscape of medical device regulations. We can help with regulatory strategy development, preparation of regulatory submissions, and compliance audits.

Fig.2 Quality management system support

By choosing our medical device validation and verification services, you can benefit from our expertise and ensure that your device meets the highest standards of quality, safety, and regulatory compliance. We are committed to partnering with you to bring your medical device to market successfully while mitigating risks and ensuring patient safety. Contact us today to discuss your specific validation and verification needs.