medical device regulatory solutions - Device Design & Development - Ann Arbor, MI
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Device Design & Development

Medical Device Design & Development » » »

                                         » » » 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