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Unlocking Success with ISO 10993-1: Biological Evaluation of Medical Devices

John E. Lincoln
Date & Time: All Days
Duration: 90 Minutes
Category: Pharmaceutical
Type: Recorded Webinar

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

Price Details

Speaker Profile : 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 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.