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Understanding Biocompatibility for Medical Devices

PTI
Course summary
2 days
English
City of London
Professional Training

Course description

Biocompatibility assessments are an essential part of submissions to regulatory agencies for medical devices. This course will provide you with a solid understanding of the principles behind crucial regulations and issues within biocompatibility. 

Supported by a wealth of examples and two practical sessions, this course will give you an in-depth look at ISO 10993. Over two days, you will examine the biological evaluation process and will improve your understanding of testing end-points and testing alternatives.

Suitability - Who should attend?

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

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

Training Course Content

  • Understand how biocompatibility and biological safety have developed
  • Comprehend the core structure and content of ISO 10993
  • Learn how to categorise devices for biological evaluations
  • Understand how to use the Annex A.1 table to identify end-points
  • Examine materials characterisation
  • Consider when in-vivo testing may be necessary
  • Review sterilisation options
  • Investigate global requirements

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:

4/5

85% had applied content during the course to their role

Delivery rating:

4/5

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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Contact info

PTI

London

 Show phone number
http://www.pti-global.co.uk


Reviews

Average rating 5

Based on 2 reviews

Quality Engineer, Bespak
(5)
I enjoyed getting a better understanding of the requirements through the workshop!
Clinical Project Scientist, JRI Orthopaedics
(5)
The course provided full knowledge on the topic, also covered all of ISO 10993 and international aspects.
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Reviews
Course rating
(5.0)
Based on 2 reviews
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