Medical Device Specialist

  • Risk-based analysis FMEA and remediation across multiple products including implants, combination drug/medical devices
  • Bill of Material Structure and Device Master Record Structure
  • Design History File Structure
  • Medical Device Software and Software Applications
  • Design for Manufacturability and Cost Reduction Opportunities
  • Safety Event Reports of Investigational and Marketed Drugs/Medicinals
  • EU Medicinal Dossier Design and Preparation
  • ISO 13485:2016 Medical Devices - Quality Management Systems (QMS)
  • ISO 14971:2019 Medical Devices - Application of Risk Management to Medical devices
  • Safety Reporting (Complaints, Medical Device and Manufacturer Incident Reports (MDR and MIR) 
  • Field Action (Recalls/Corrections/Removals) and Stock Recovery Systems Planning and Execution


Looking for help from an experienced pharmaceutical consultant?

To discuss your next medical device project contact Joe Baker at JLBaker Consulting by phone or email.

JLBaker Consulting

Summerville, SC and Ogden Dunes, IN 801.703.8327