Understanding the Role of your Expert Witness

Why Should You Attend:

The responsibilities of proving liability on the part of the medical device expert witness are extremely challenging and require a knowledge of FDA regulatory protocols including premarket approvals and FDA design controls; good design practices for all types of medical design practices; an expertise in the research and development of medical devices; and the proper use of medical devices. The Expert Witness may be required to develop a written report which should be based on a rigorous engineering analysis of the device and experiences and knowledge of the proper functioning of the device which he/she has been requested to provide his/her opinions for the potential cause(s) of a device which has not provided the appropriate therapy as it had been designed for. This report needs to be well written and include a discussion of the adherence or lack of adherence to FDA device controls.

Experts should have a thorough background in FDA regulatory and EU control issue related to the specific device which there are providing their Expert Opinions on. More specifically The Expert should have the expertise in the following regulatory issues/protocols:

• 21 CFR 820
• 90/385/EEC regarding active implantable medical devices
• A Guide to the EU Directive Concerning Liability for Defective Products (Product Liability Directive)
• Applying Human Factors and Usability Engineering to Medical Devices
• Design verification/validation and process validation
• Directive 93/42/EEC covering medical devices modified by the directive 2007/47/CE
• EU-Medical Device Regulations MDR/2017
• FDA Design Considerations
• FDA verification and validation procedures
• ISO 10993-1 - Biological evaluation of medical devices - Part 1
• ISO 13485 Medical devices -- Quality management systems
• ISO 14937:2009 - Sterilization of health care products
• ISO 14971 - Medical Device Risk Management
• ISO 9001:2015 Quality management systems - Requirements
• ISO/TR 80002-2:2017 - Medical device software -- Part 2: Validation of software for medical device quality systems
• MAUDE - Manufacturer and User Facility Device Experience
• MEDDEV 2.7.1 rev 4 and Clinical Evaluation Reports (CER) for Medical Devices
• Medical Device Directive 93/42/EEC regarding medical devices
• Medical Device Reporting - 21 CFR Part 803
• Premarket Medical Device Submissions

Areas Covered in the Webinar:

• Preparing your Expert Reports
• Avoiding Daubert Challenges
• Understanding all FDA regulatory issues related to class II and class III devices
• How to effectively review and evaluate MDRs, Recalls and other FDA related events
• Working more effectively with attorneys representing either the Plaintiff or defendant side
• Preparing for Depositions
• Understanding your role as medical device expert witness
• Reviewing all design, manufacturing and quality assurance documents

Who Will Benefit:

• Medical Device Expert Witness, Attorneys involved in medical device liability, Medical Device Manufactures of Class III medical devices

Free Materials:

• Reference documents
• Rule documents or guidance
• Checklist
• SOP template
• Easy fill in forms
• Articles

George Yanulis
President, Medical Device Consulting LLC

Dr. George Yanulis has consulted in Medical Device Product Development and Research for 20 years and has a Doctorate and Master’s Degree in Biomedical Engineering. He has conducted cardiovascular device research at the Cleveland Clinic Foundation on cardiac pacing paradigms used in heart failure patients. In addition, Dr. Yanulis has been involved in the R&D Medical Device Consulting & Litigation Support as an Expert Witness for over 10 years and has been involved in numerous medical device liability and patent infringement cases. He provides expertise to attorneys, medical device companies, health care systems and insurance carriers related to FDA medical device controls, PMAs, post-market surveillance issues, medical device/product failures and IP medical device issues. In addition, he has reviewed MDR(s) and other adverse events related to implant device failure. Dr. Yanulis is highly motivated in maintaining and providing the highest level of quality in the design, development and safe and effective use of all types of cardiac device implants.

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