IoMT Recycling Solutions is ISO 13485-Certified

What You Need To Be Compliant

ISO 13485 standard facilitates reduced safety and legal risks. Certification helps companies get recognized as more reputable, trustworthy providers because it is an internationally recognized standard.

The standard contains specific requirements for manufacture, installation, servicing, and end of life tracking of medical devices, including:

• Implementation of a Quality Management System with several enhancements
• Risk Management approach to product development and product realization
• Validation of processes
• Compliance with statutory and regulatory requirements
• Effective product traceability and recall systems

How We Can Help

Certification requires a risk-based approach for control of external providers of services. Service providers of high risk processes will require a higher level of control in evaluation and selection. These risks are in reference to the safety and performance of the medical device, however risks related to end-of-life processes also need to be considered. Destroying devices at end-of-life will protect you from data breaches, unauthorized use, and the secondary market.