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Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems

  January 20, 2018  
CfPIE - The Center for Professional Innovation & Education, Malvern, PA USA
June 25 & 26, 2018

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

The changes to the EU post market requirements for Medical Devices are extensive – a direct response to users and regulatory agencies becoming less ‘tolerant' of medical device risks and failures.

A far greater emphasis placed on Post Market Surveillance improving Risk Management to protecting public health, places increasing requirements on Medical Device Manufacturers. This course will review the existing and emerging regulatory expectations (FDA, EU and others) for Post Market Surveillance including the new EU Requirements for Clinical Evaluation and Post Market Clinical Follow-up (PMCF).  The course outlines practical steps for developing and implementing systems and procedures to comply with the increasingly more stringent requirements for Medical Devices.

Topics include:

  • Complaint handling & vigilance systems
  • Medical Device Reporting
  • Risk Management & ISO 14971
  • Implementation challenges
  • Medical device tracking
  • Impact of post approval studies
  • Compliance requirements & meeting them
  • Complaint systems inspections.

Throughout the course, examples and case studies together with the extensive resource material provided, help participants apply these important concepts and requirements.

Who Should Attend

This course is intended for medical device professionals involved in post market surveillance, complaint handling and regulatory compliance; however, professionals in associated disciplines are encouraged to attend, including:

  • Post Market Surveillance
  • Complaint Assessment & Handling
  • Quality Assurance
  • QMS & Compliance Management
  • Risk Management
  • Regulatory Affairs
  • Clinical Affairs
  • Medical Directors
  • Manufacturing
  • Research and Development
  • Recall Coordinators
Organized by: Center for Professional Innovation & Education
Invited Speakers:

Jonathan Lee

Jonathan Lee

Specialties: Regulatory

Jonathan Lee has more than 25 years of broad-based medical device experience with extensive Quality System experience encompassing ISO, MDD & GMP standards and regulations, through consulting and senior management positions in QA/RA, R&D, Project Management, Product Management, and Product Introduction disciplines, in both the United States and Australia.

A multiple patent holder, Mr. Lee’s prior roles include VP R&D at Cardiac Control Systems, Vice President Quality, Regulatory & Clinical affairs at Medtronic. In addition, his consulting roles supporting implantable bio stimulation telemetry systems, implantable heart sub-system, catheter defibrillation system, surgical tool, vertebral stiffness measuring system, respiratory interfaces, cardiac catheter development, medical device process V&V, quality system development & implementation, and product approvals, have provided for an extensive accumulated experience.

Today, as Principal Consultant and Managing Member of “MedDev Consulting Solutions International” he provides strategic direction and tactical solutions for unique medical device challenges. Including areas such as integration of quality systems with compliance, product performance and elevated stakeholder expectations.

Mr. Lee holds an Electrical Engineering (Biomedical) BE degree from the University of NSW in Australia with post graduate work in Computer Studies at the same University. He has participated in compliance symposia at Harvard University and served as an instructor on quality systems at University of Southern California School of Pharmacy Master’s Degree Program.

Deadline for Abstracts: N/A
Registration: https://www.cfpie.com/ProductDetails.aspx?ProductID=264
E-mail: info@cfpie.com
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