Bellus Medical Raises the Standard in Microneedling Industry by Receiving ISO 13485:2016 Certification

ISO 13485:2016 Certified

I’m very proud to have received the ISO 13485:2016 certification. It allows us to demonstrate and show from a third party certification that Bellus Medical is the company we say it is.

Bellus Medical, a leader in medical aesthetics products and devices, recently earned the ISO 13485:2016 certification. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. This certification has been established by the International Organization for Standardization (ISO), the largest developer and publisher of international standards. These standards ensure Bellus Medical meets world-class specifications for products, services and systems, to ensure quality, safety and efficiency.

“The ISO 13485:2016 certification proves the strength of our organization, demonstrates our commitment to quality, and builds our customers’ confidence as their trusted partner,” said Joe Proctor, Bellus Medical President and CEO. “I’m proud to recognize this significant milestone for our company, making Bellus Medical the only microneedling provider to meet the ISO 13485:2016 standards.”

Certification requirements

  • Documenting policies for record controls, internal auditing procedures, non-conformance controls, preventative and corrective actions, process and design controls, record retention, accountability and traceability.
  • Risk management must be thoroughly documented and conducted throughout a product’s entire lifecycle, from initial concept to delivery and post-delivery.

Benefits of ISO 13485:2016 certification

  • Access to…

Read the full article from the Source…

Leave a Reply

Your email address will not be published. Required fields are marked *