Risk Assessment Classification of Medical Devices Remediation
Revolutionary, secure work from home program established.
A European orthopedic medical device company began their EU MDR compliance initiatives but, due to the global COVID pandemic, were forced to put the project on hold. Since the company previously experienced Oxford Global Resources’ unique ability to source experts with niche skill sets quickly, they contacted us to evaluate their options. After discussing the possibilities with Oxford’s SMEs and industry leaders, they made the determination to pursue a proactive approach and continue the initiative.
We facilitated a revolutionary work from home program for the organization which they had previously been unable to explore due to security concerns. However, we devised a solution that protected all proprietary information from an infrastructure and security standpoint.
Within a minimal timeframe, we provided a team of experts to continue the project, including: a Senior Project Manager, DHF Remediation Experts, Biocompatibility Consultants, Risk Management Consultants, Product Compliance Experts, an Interim QA Manager, Labeling Project Manager, and several Quality Engineers all experienced in MDR.
Oxford’s consultants provided support in the following areas:
Risk assessment (ISO 14971)
Medical device classification
Tech file remediation
Unique Device Identification (UDI)
Labeling updates and compliance
The twelve consultants were essential in completing the broad scope of tasks required for implementation of several Class I, II, and III devices. Their duties included project controlling and coordination, gap analysis, updating timelines, regular status reports, collaboration with in-house departments and the requisite Notified Body, and reviewing, planning, and updating tasks for technical documentation. During the initiative, Oxford’s Project Manager identified gaps within the current change management process and notified the client. Because of this, the client updated their processes and aligned them to suit their needs now and in the future.
Oxford’s team of consultants remain on task to hit the project goals, timelines, and deliverables. We continue to partner with this client to achieve their long-term MDR goals.