ISO 14971:2007 Medical Devices – Application of Risk Management to Medical Devices
Competitive Advantages of ISO 14971:2007
- ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
- Increase access to more markets worldwide with certification
- Meet regulatory requirements and customer expectations
- Increase efficiency, cut costs and monitor supply chain performance
- Demonstrate that you produce safer and more effective medical devices
Process Flow
Initial
Consultation
Our consultant will contact you to gather information about your organization to understand your company needs and ISO standard requirements.
Gap Analysis and Planning
Assess your organization’s current practices and identify gaps. Develop a plan to address the gaps and achieve ISO compliance.
Documentation and Implementation
Develop necessary documentation, policies, and procedures. Implement the changes and new processes within your organization.
Training and Awareness
Provide training to employees on ISO standard requirements and their roles in the implementation.
Internal Audits
Conduct internal audits to assess the effectiveness of the implemented ISO management system and identify areas for improvement.
Certification Audit and Issuance
Receive the ISO certification, upon successful audit from an accredited certification body.