ISO 13485

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable FDA regulatory requirements.

SBS Software tools help with efficient compliance to ISO 13485:

SBS Product Key Features
T-Med Database · Maintain training records
· Record certification and re-certifications
· Evaluate training effectiveness
· Email delinquency notices
· Manage training compliance
· CFR 21 part 11 compliant
 
Q-Med Database · Manage corrective actions (CARs)
– Safety and Supplier CARs (SCARs)
· Manage preventive actions (PARs)
· Internal audit management
· Document Quality Management System reviews
· Manage continual improvement projects
· Monitor and measure customer perceptions
· Manage and assess risk (FMEA / SWOT analysis)
· CFR 21 part 11 compliant
 
Ground Control · Complete document life cycle management
· Develop training requirements / training plans
· Track training based on new document releases
· Record certification and re-certifications
· Evaluate training effectiveness
· Email delinquency notices
· Manage training compliance
 
Asset Tracking · Control of monitoring and measuring devices
· Calibration recall list
· Manage preventive maintenance on critical equipment
· Time based PMs or counter based PMs
 
Vendor Management · Develop Vendor qualification plans
· Record qualification results
· Maintain your Approved Vendor List (AVL)
· Establish criteria for selection, evaluation and re-evaluation of suppliers
· Link electronic files (paperless system)