Our Services

Consulting

Commissioning, Verification/Qualification, and Validation

Controls and Automation

Medical Device Design Control

Process and Cleaning Validation

Process Engineering

Medical Device Design Control

Our expertise in the medical device industry touches upon all aspects of the Quality Management System (QMS), including R&D activities. The skills of our medical device team are uniquely suited to support your needs for compliance to FDA 21CFR Part 820, ISO13485, ISO14971, the Medical Device Directive (MDD), Part 11 compliance and other applicable FDA and international regulations.
 
Our medical device specialists have extensive design controls experience supporting new product development projects, including:
  • Design history files
  • Device master records
  • Design input development
  • Risk management (Risk Plans, FMEAs, hazard analysis, etc.)
  • Design verification and validation
  • Test method development
  • Test method validations (TMVs)
  • Gage R&R
  • Supplier quality
  • Component qualification
  • Design transfer