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Fundamentals of Biocompatibility for Medical Devices

Course summary
4 weeks
Online courses
Professional Training

Course description

Fundamentals of Biocompatibility for Medical Devices

Within medical devices, biocompatibility assessments are essential in the early stages of development to safeguard patient safety. Notified Bodies must see adequate data on biocompatibility (in accordance with ISO 10993) to be sure a device is biologically safe.

Over four weeks this course will provide you with a baseline understanding of key requirements under ISO 10993 and what you need to include in an evaluation to ensure compliance. In addition, you will be able to understand biocompatibility in the context of risk management, and safety requirements under the Medical Device Regulation (MDR) and from a global perspective, cemented by a series of case studies.

Suitability - Who should attend?

This course will be useful for anyone new to biocompatibility for medical devices, who would like a refresher of this material or to update their understanding of regulations, including:

  • Regulatory Affairs
  • Quality Assurance
  • Manufacturing, development and design
  • Toxicology
  • Process development

Outcome / Qualification etc.

  • Understand the relationship between biocompatibility testing and ISO 14971
  • Analyse ISO 10993-1 and its updates
  • Explore material characterisation in its different forms
  • Examine the MDR safety requirements in the context of biocompatibility
  • Recognise the differences in the EU MDR and FDA 510(k) approaches
  • Review the relevant End Points for Consideration

Training Course Content

  • Module 1: Introduction to Biocompatibility
  • Module 2:  Risk Management
  • Module 3: ISO 10993-1
  • Module 4:  Material Characterisation
  • Module 5: MDR Safety Requirements
  • Module 6:  International Perspectives
  • Module 7:  End Points to Consider

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About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...

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