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.
Medical Device Intelligent Insights™ Report
$139.99
Description
This quarterly newsletter includes:
Executive Summary
Device – Citation Total & Category Breakdown
Device – Quarterly Breakdown
Device – Total Quarterly Citations
Device – Category Total
Device – Packaging/Clinical Totals
Device – Packaging/Clinical Quarterly Trend
Device – Top 8 Subsystems & Quarterly Breakdown
Device – Quarterly Breakdown
Device –Records Subsystem & Production Controls
Device – Production Controls
Device – Total Citations
Device – Subparts G, H & Clinical Activity
Device – Clinical Activity, Quality Requirements, Design Control, CAPA
Device – cGMP Systems Definitions
CFR Title 21 Parts 1 to 1499
CFR Title 21 Part 820
CFR Title 21 Part 803
Medical Device Single Audit Program Links
Device – Warning Letters
The publication also provides over 12 charts and graphs providing clear graphical data highlighting current regulatory trends for medical devices. An executive summary provides a synopsis of all data presented in the newsletter and significant changes in regulatory trends. Current Good Manufacturing Practices, Packaging and Clinical categories are successively drilled down to identify the top 8 citations for devices. Key medical device regulatory subparts are identified through charts and graphs. Active links to all warning letters for the time period reported are provided as well as links to FDA regulations for easy reference without the need to navigate the FDA website. Among the many uses, newsletters are used to objectively evaluate risk, prioritize audit observations and corrective actions, prepare for internal audits and as training tools in addition to defining regulatory.
