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Medical Device Testing

 Andrew Makin
  10th-Nov-2017
Description: Potential of leachable substances either in extracts of the device or directly from the device to cause irritation on different parts of the body.
Views: 707
Domain: Medical
Category: Equipment
Contributing Organization: Norway Health Tech
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Maxims of Tech: Rules of Engagement for a Fast Changing Environment
Contents:
Medical Device Testing
Andrew Makin, MSc, ERT, MRSB
Scientific Director
CiToxLAB Scantox, Denmark

Medical device

Pharmaceutical product

Risk evaluation

Preclinical studies
• Genetic Toxicology
• Toxicology
• Safety Pharmacology

Efficacy

Biocompatibility

Clinical testing

Phase I Clinical studies
Preclinical studies
• Toxicology
• Reproductive Toxicology
• DMPK ... See more

Medical Device Testing

Medical Device Testing - Andrew Makin, MSc, ERT, MRSB, Scientific Director, CiToxLAB Scantox, Denmark

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04 December, 2017