December MSCE Meeting
DATE: Wednesday, December 14, 2022
TIME: 5:00 PM – 7:00 PM
PRESENTER: Jahan Azizi with HealthMark
TOPIC:ANSI/ISO standards role in device development, approval, and maintenance of medical devices. (1 Credit Hour approved by AAMI)
Understanding the process of Standards development and their utilization in product development, the FDA review process, and what goes into getting medical devices to market. It also helps with the understanding of the validation, testing, approval processes, and once the medical devices are in use.
The HTMs’ participation in standards development is essential in incorporating the user’s needs and requirements.
Objective 1 – Define Medical Device per the Food and Drug Administration (FDA)
Objective 2– Discuss how to Determine if a Product is a Medical Device and the FDA review process for Class I, II, III medical devices.
Objective 3- Discuss the standard’s role in product development, the FDA review process, and users.
Objective 4- Discuss the role of the AAMI in standards developments.
Objective 5- FDA consensus standards list.
Objective 6- The importance of HTMs’ involvement in standards development. How to get involved? List of Standards need HTMs’ professionals’ participation.
Jahan Azizi is a certified Biomedical Equipment Technologist with more than 35 years in healthcare settings investigating and reporting problems with medical devices, his focus has always been on fixing and correcting, then moving on to the next.
Jahan has spent several years on the issue of validating and optimizing surgical instrument reprocessing methods. Jahan has worked in healthcare settings, device manufacturing, and at Food and Drug Administration as well.
Jahan has written numerous safety reports, internal reports, presentations, and hospital policies. He has published the findings from his work, better to reach those in industries and in regulatory agencies that can effect positive changes in medical device design, maintenance, and control.
2019-Present AAMI Committee(s), Working Group(s) or TAG(s), Primary Voter:
• EM ,Electromagnetic Compatibility Committee
• HE , Human Factors Engineering Committee
• QM , Quality Management and Corresponding General Aspects for Medical Devices Committee
• QM/WG 04 , Application of Risk Management to Medical Devices Working Group
• QM/WG 06 , Application of post-market surveillance systems to medical devices
• EQ-WG04 Alternative Equipment Maintenance
FACILITY: Schoolcraft College Manufacturing & Engineering Center
MEETING LOCATION: 13001 Merriman Rd, Livonia MI 58150