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Biological Evaluation of Medical devices, Biocompatibility of Materials and Process

Picto Training Biological Evaluation of Medical devices and BiocompatibilityPrinciples of ISO 10993-1

  • The relation between the ISO 10993-1 and the essential requirements of MDD 93/42/EEC
  • Other standards involved for the ISO10993-1 Implementation.
  • Input data of the ISO10993-1 Application

Approach and Methodology according to ISO 10993-1

Elements to take into account for the Product Assessment

  • Definition of Material or finished product for the Pre-Clinical Evaluation
  • Classification of Medical Devices
  • Biological Assessment Process
  • Biological Testing / Pre-clinical Testing
  • Biological Technics :Methods and Analytical Technics
  • Chemical Technics :Methods and Analytical Technics

Approach of Risk Management Process for Medical Devices Biological Evaluation

  • Biocompatibility of Materials & Biocompatibility of Processes
  • Information on Post-Production, Feedback, and Materiovigilance
  • Review of Scientific Literature: Methodology
  • Review of Scientific Literature: Recommendations
  • Review of Scientific Literature: Preparation of the Report

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Due to our rapid growth in North America, we're seeking Lead Auditors, Certification Project Manager Active and Non-Active Medical Device responsible for medical device manufacturing clients.

Training - 2 Days Course

Training EU Medical Device Regulations

 

European Medical Device Regulation 2017/745

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Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

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Our Clients Say

"We traveled from Massachusetts to attend the 2days LNE/G-Med ISO 13485:2016 and ISO 9001:2015 transition training and it was well worth the trip. The training was interesting, informative and interactive. The case studies were a great way to try and apply the new aspects of the standards and brainstorm with others. The chance to meet and discuss the new standards with actual LNE auditors was a huge plus."
Dan Massucco - Vice President of Quality Assurance and Regulatory Affairs

"I just thought you might like to know that we completed our transition audit with only three minor NCs. The auditor was very impressed that we did this on our own without the benefit of a consultant. I give much of the credit to your training class and want you to know that I really think you did an excellent job with the training."
Sue Powell - Quality Manager