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John E. Lincoln
Unlocking Success with ISO 10993-1: Biological Evaluation of Medical Devices
Pharmaceutical
Recorded Webinar
All Days
 90 Minutes
Description

Join us for an informative webinar where we dive deep into the world of biological evaluation of medical devices using the international standard ISO 10993-1. This standard, titled "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," is a crucial guideline for ensuring the safety and efficacy of medical devices in the global market.

Key Highlights:

  • Understanding ISO 10993-1:  Gain insights into the fundamental principles and scope of ISO 10993-1 and why it is essential for the medical device industry.
  • Biocompatibility Assessment:  Learn how to conduct biocompatibility assessments for your medical devices by ISO 10993-1.
  • Risk Management:  Explore the integration of ISO 10993-1 within your risk management process, ensuring compliance and safety.
  • Case Studies:  Dive into real-world case studies showcasing successful implementation and compliance with ISO 10993-1.
  • Q&A Session:  Engage with our expert panel in a live Q&A session to get answers to your specific questions.

Why Attend?

  • Learn about the latest requirements for ISO 10993-1 compliance
  • Get expert advice on how to implement ISO 10993-1 in your organization
  • Ask questions and get answers from experienced professionals

Who Should Attend?

  • Regulatory Affairs Professionals
  • Quality Assurance Specialists
  • Biomedical Engineers
  • Product Development Teams
  • Medical Device Manufacturers
  • Anyone involved in the medical device industry
Training Options
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Total
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Speaker

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO...