Enhance your medical device safety with comprehensive risk management services

In the medical device industry, ensuring patient safety and regulatory compliance is essential.

Implementing a robust risk management framework in line with EN ISO 14971 is necessary for identifying, evaluating, and mitigating potential risks throughout a device's lifecycle. At Valicare, we specialize in guiding manufacturers through the complexities of risk management, ensuring your products meet the highest safety standards and comply with global regulations.

Our EN ISO 14971 risk management services include:

• Risk management process development
  We assist in establishing a comprehensive risk management process tailored to your organization's needs, encompassing risk analysis, evaluation, control, and monitoring activities as outlined in EN ISO 14971.
• Risk identification and analysis
  Our experts facilitate systematic identification of potential threats associated with your medical devices, conducting thorough risk analyses to assess the probability and severity of harm.
• Risk evaluation and control implementation
  We support you in evaluating identified risks against acceptable criteria and implementing effective risk control measures to mitigate or eliminate them, ensuring compliance with regulatory requirements.
• Documentation and reporting
  We provide guidance on maintaining detailed risk management documentation, including risk management plans, reports, and records, to demonstrate compliance during audits and regulatory submissions.
• Training and education
  Empower your team with our tailored training programs on risk management principles, EN ISO 14971 requirements, and best practices for maintaining a culture of safety and compliance within your organization.

Partnering with Valicare ensures that your risk management processes are robust, compliant, and effectively integrated into your quality management system. Our dedicated team of specialists brings extensive industry experience, providing personalized solutions that enhance the safety and reliability of your medical devices.

Contact us today to learn how we can support your journey toward comprehensive risk management and regulatory compliance in the medical device sector.