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Design Control

Reduce costs and time to market with efficient development systems

All successful regulatory submissions are supported by FDA compliant Design Control and Review systems. Quality System Regulations (21 CFR 820 :QSRs) and ISO 13485 require documented design review according to written procedures, with results maintained in a documentation system (Design History File). Read more in Compliance about Quality Systems

As a start-up medical device project you may need help implementing:

  • Quality System documented SOPs
  • Design plans
  • Design review meetings
  • Change control for documentation of changes to design inputs and outputs
  • Design History File and development records
  • Documented customer inputs
  • A documented development plan that supports the product development process
  • Design Level Hazard Analysis and Risk Assessment
  • Design verification and/or validation tied to risk analysis and technological differences Read more about Qualification
  • Soundly crafted output documentation relevant to regulatory submissions and compliant with standards and guidance document requirements
  • Design transfer and process validation Read more in Qualification
Paladin Medical University of Kentucky Department of Biomedical Engineering Paladin Medical Society for Biomaterials Paladin Medical Regulatory Affairs Certification Paladin Medical American Institute for medical and Biological Engineering