Dental Appliance
Dental Appliance
Services Provided
Program / Project Management
Risk Management
Regulatory / Quality
Systems Engineering
Verification & Validation
Client Background:
The client, a leading provider of dental and orthodontic devices, required help with documenting their processes and remediating a Design History File to address a recent FDA 483.
Client’s Request(s):
The client, a leading provider of dental and orthodontic devices, required help with documenting their processes and remediating a Design History File to address a recent FDA 483.
Document our Design Process to comply with industry requirements and standards.
Propose and implement a Quality Management System (QMS), capturing data on complaints and failures.
Remediate the DHF for a Mandibular Advancement Device.
Project Actions:
Concise Engineering assumed the lead as a project management service, proceeding to deliver the following deliverables:
Reviewed the existing design of the device
Captured and documented the device’s requirements
Evaluated the device’s design against newly articulated requirements
Developed test protocols
Executed verification testing
Also, Concise Engineering performed stress and reliability testing for the device.
Outcome:
Successful implementation of the new QMS system
Completed the DHF remediation to the satisfaction of the FDA
Additionally, our key team members supported this client on-site, during a follow-up inspection by the FDA.