Client Background:

Manufacturer produces devices replace bones, joint, or cartilage due to damage or deformity. The manufacturer of orthopedic implants is intended to be used as fixation implants for bone fractures, joint fusion, bone reconstruction, or as guide pins for inserting other implantable devices).

Client Problem:

The client wanted to obtain the ISO 13485 certificate but struggling to find the right person for the audit. Their team had no experience in handling ISO audits and the time was running out.

ND Global Solution & Approach:

ND Global developed QMS templates in accordance with the ISO 13485 standard. The customer received a thorough Gap Assessment from us and consultation support to close any gaps in their manufacturing site and ISO standard.

Project Achievements:

Based on their positive experience, the customer extended the scope of work to seek support for Health Canada-compliant documentation for this device.

Project Outcomes:

The manufacturing site received an ISO 13485 certificate after the Notified Body reviewed and accepted the QMS documents without making any observations.