Webinar IDDD:   MD3187

ISO 14971:2019 Medical Device Hazards and Risk Management – All you need to know

  90 Minutes

Hazard Analysis / Risk Management is a required in device development, validation, CAPA investigations / resolutions, and most other cGMP considerations.

Both the U.S. FDA and the EU’s MDD/MDR require companies to be proactive in reducing product risk while increasing user benefits. What “risk” is to be analyzed? One of the best tools to achieve and document this is ISO 14971 for devices. Recently ISO 14971 was changed. The 2019 version is replacing the 2014. What does that mean for medical device designers, specification developers, manufacturers, QA and RA? How should the change be managed?

Common considerations: Many cGMP activities must be “Risk-Based”. What does that mean; what does it not mean? – An important distinction, which, when neglected, has resulted in several Warning Letters from the US FDA. How does ISO 14971 address risk-based.How is it mandated to be used in software verification and validation.

How does it impact CAPA / NCMR / Complaint investigations. Many firms use some product risk management tools, but are not compliant to ISO 14971 in any version, for devices. What changes would be necessary to become compliant? What are Europe and U.S. regulatory expectations? What benefits beside regulatory compliance can be achieved for a company?

Why You Should Attend:

In this important webinar, see the elements recommended or expected to be in the Risk Management File / Report. Learn how to blend ISO 14971 into a company’s cGMP system, which is a requirement of regulatory agencies. What should be the areas of focus. Make the document a “living” document. Achieve major business benefits by regular use of the Risk Management File / Report in training, marketing, validation, root cause analysis, CAPA activities and failure investigations, as well as the obvious, increased product safety and reduced liability.

Areas Covered in the Session :

  • The Changes; Timelines
  • Key Requirements of ISO 14971
  • Suggested formats
  • Expected sources of information to evaluate
  • What to include
  • How to complete, document, and control
  • Areas of contraversy
  • An often neglected safety feature
  • A “living” useful, cost-saving document
  • Is it being used to its full business benefit?

Who Should Attend:

  • Quality Assurance Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Validation Departments
  • Documentation Departments
  • Consultants


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.