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                                         » » » Expertise & Support Services
» Comprehensive Preliminary Regulatory Strategies For Device Development
»  Clinical User Needs & VOC Assessments
»  Product Requirements Specification (PRS) Development Support-Design Inputs
»  Medical Device Risk Management Expertise & Support Services
   - We Help Your Team Prepare Your Product's Preliminary Hazard Analysis (PHA)
   - We Help Your Team Prepare & Implement Risk Management Plans
   - We Help Your Team Prepare & Update D-FMEAs and P-FMEAs
»  Compliant Engineering Change Control Documentation Training & Support
»  Support To Establish / Remediate Design History Files  (DHFs)
»   Regulatory Support For Design Reviews & Independent Reviewers
»  Regulatory Support For Design Verification Activities
»  Regulatory & Engineering Support For Device Performance Validations
»  Process Validation Plans & Implementation Support - IQ, OQ & PQ
»  Device Master Record (DMR) Preparation & Review Support
 
Contact Us For A Comprehensive Design Control SOP Package
 
MDRSllc FDA Design Control Overview