Medical Device Directive
The FDA and EU dictate current medical device directive.
The FDA and EU dictate current medical device directive. These directives seek to define and regulate the document and quality control processes that surround the manufacture of medical device products. Over 400 regulated companies around the world use MasterControl's integrated document and process management system to address the challenges of regulatory compliance. MasterControl customers automate, streamline, and effectively manage the document and quality processes of their companies.
White Paper Downloads
About MasterControl Inc.
MasterControl Inc. provides the leading document and process management system on the market. With over a decade of experience in the FDA and EU environments, MasterControl offers real solutions to real industry challenges. MasterControl created the first document management and quality system that directly addressed the industry specific needs of companies regulated by medical device directive.
Comply with Current Industry Medical Device Directive
It is possible to attain and sustain compliance with current industry medical device directive. Whether it is FDA or EU regulations, the MasterControl system goes beyond software to provide an integrated approach that keeps companies compliant, connected, and complete. The integrated quality management software addresses medical device directive with configurable applications that can be implemented according to the unique needs of each company. These applications include the following:
- MasterControl Documents™
- MasterControl CAPA™
- MasterControl Training™
- MasterControl Forms™
- MasterControl Change Control™
- MasterControl Audit™
- MasterControl Customer Complaints™
- MasterControl Nonconformance™
- MasterControl SOX™
- MasterControl Submissions Gateway™
For More Information
Regulated companies who know more, succeed sooner in the stringently regulated FDA and EU environments. MasterControl's Resource Center provides comprehensive educational and research materials about current medical device directive, industry issues, and their integrated quality management system. The Resource Center includes the following materials:
- Product Data Sheets
- White Papers
- Q&As
- Tech Papers
- Case Studies
- Online Demonstrations
Questions? Contact MasterControl Today MasterControl's document and process management system is an integrated, easy to use approach to compliance with current FDA, EU, and medical device directive. Along with configurable software applications, MasterControl also offers time-tested product training , implementation , and validation services .
Contact MasterControl online or call toll free at 1-800-825-9117.
Related Items:
- Regulatory Compliance
- Document Control Software
- Training Management System
- Quality Management Training
- Document Management Product
- FDA Compliance
|
