S3 Launches ISO 13485 Compliant Quality Management System
September 8th, 2008 - S3’s ISO 13485 compliant QMS enables our customers to deliver medical devices and related services that conform to the ISO 13485:2003 standard and meet the CE and FDA CFR Title 21 Part 820 regulatory requirements. We provide a comprehensive set of policies, processes, standards, procedures and tools that can be set up on a customer site. In addition, we analyze the specific needs of our customer’s organization, including customizations and changes required, and provide them with process-based implementation services to enable them to roll out the QMS into practice and build a Culture of Quality within their company.
BENEFITS
- Enables and significantly accelerates the establishment of a Quality Management System for an organization that can be certified to ISO 13485
- Ensures that medical devices and services are developed with a process that will meet the U.S. and European regulatory requirements
- Improves the quality of medical devices and related services that are developed to these processes
- Reduces risk
To download more details please click here http://www.s3group.com/fileadmin/user_upload/documents/Health_FY_ISO13485_v1_www.PDF
Date Published: Monday 01 September 2008
