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PRODUCT LIFECYCLE MANAGEMENT/DHF CONSULTING & REMEDIATION

PRODUCT LIFECYCLE MANAGEMENT/DHF CONSULTING & REMEDIATION

  • Product Specification Development
  • Verification and Validation Procedure Development
  • Risk Analysis
  • Fault Tree / FMECA Analysis
  • Process Validation
  • Product Design History File, Verification and Agency
  • Testing Remediation
  • Regulatory and Non Compliance Remediation
  • Project Work Plan Development
  • Consent decree remediation and product support
  • Design changes to mitigate non-compliance issues
  • Provide DHF documentation
  • Gap Analysis, DHF and Agency compliance and mitigations
  • Risk Analysis, Requirements, Test Protocols, Testing, Traceability
  • 60601-1 Gap Analysis and remediation

Phone Number

CHI:(224) 585-3870

IND:(317) 763-0278

address

222 Merchandise Mart Plaza Suite 1230 Chicago IL 60654

12175 Visionary Way Suite #400 Fishers IN 46038

e-mail

info@amdd.com

Agile Medical Device Design (AMDD) follows the ethos of agile development methodology in all engineering disciplines (Human Factors, Electrical Engineering, Mechanical Engineering, Software Engineering and System Engineering) to solve complex medical device development and design challenges.

 

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AMDD welcomes small projects as well as large ones. We help with all phases of the product development process, from early concept testing to product launch.

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