Medical Devices
People are becoming increasingly reliant on some sort of medical device ranging from contact lenses to prosthetics to implantable cardiac devices including stents, pacemakers and defibrillators. It is a multi-billion-dollar industry that is growing every day. For manufacturers of medical devices, staying on top means knowing the requirements and how to quickly resolve issues. Our products help you navigate this heavily regulated industry. We offer the expertise and tools that help you identify potential issues, prevent violations and provide viable solutions which mitigate risk and improve overall compliance success.
Resources
- • Insider Intelligence Reports – A rolling 24 month trend of medical device regulatory activity providing insight into areas of regulatory compliance risk. Included in the reports are active links to all medical device regulations and medical device warning letters for the 24 month report period.
- Dashboard Visualizations – Standard and/or custom visual dashboards providing detailed trends and information of all medical device activity for all or part of the time period from 2012 through present. Visualizations are used to enhance management review, organizational collaboration, risk management, audit preparation and many other value-added activities.
- Quality Process Assessments – Objective, data-based assessments utilizing validated Quality Management System best practices to deliver detailed improvement recommendations and strategic plans. Results of assessments also provide valuable data related to Quality Management Maturity improvement opportunities.
