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Number 7
​Risk control and residual risk

Risk Control
Now that you have identified risks and identified manners in which to eliminate or reduce risk, you must now implement these processes.  This could be changes in route of exposure, duration of exposure, materials, processes, geometries of the surface, and formulations of materials.  A suggestion of putting warning labels rather than testing to quantify risk.
Animal testing should be the last resort after chemical, physical and in vitro evaluations have been exhausted.
 
Residual Risk.
                After all of the previous steps, what risks still remain.
 
Post Production monitoring
Monitoring of adverse events once on the market and updating the file with newly acquired information.
​
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  • Home
  • Suppliers
    • Contract Laboratories >
      • Toxikon
      • Nelson Labs
      • Eurofins
    • Material Suppliers
    • Contract Manufacturers
    • Consultants >
      • Intrinsic Medical Group
  • Library
    • Which Endpoints Should I Consider?
    • Test Method Summaries
    • White Papers, Articles and Presentations >
      • FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires
      • FDA Recognized Consensus Standards Update
      • The Ten Steps of a Biological Evaluation whtin a Risk Management Process
      • Post-Approval Biocompatibility
      • The Failed Cytotoxicity Test
      • Biocompatibility Deficiency Letters Part 2
      • ISO 18562-1 (2017) Biocompatibility Evaluation of Breathing Gas Pathways
      • In-Vivo Thrombogenicity 101
      • Technical Considerations for Additive Manufactured (3D Printed) Devices
      • How to Pick a Biocompatibility CRO
      • Mitigating Risk in Biocompatibility
      • Biocompatibility Deficiency Letters
      • The First Steps in Biocompatibility
  • Contact
    • About
  • Search