1. ISO 14971: Preliminary Hazard/Risk Analysis standards used in the creation of medical devices. (1PDH)
BRIEF DESCRIPTION OF PRESENTATION:
Risk analysis is a critical task that is carried out when creating new medical devices. This analysis commonly precedes the creation of prototypes and manufactures must adhere to the ISO 14971 standard. This analysis helps companies develop safer medical products that are utilized by clinicians. The process itself is reviewed by the FDA prior to gaining approval to market a new device. This session covers the basic principles of carrying out preliminary hazard analyses as described by ISO14971.
Course Objective:
The objective of this session is to provide a general overview of protocol described within ISO14971 for conducting a risk analysis used in creating medical devices. While this session is imperative for all staff within the medical device industry, it is equally important in the creation of any technology where safety is incorporated into the design phase of product development.
Speaker
Greg T. Gdowski, PhD
University of Rochester Center for Medical Technology & Innovation Department of Biomedical Engineering
2. Product Presentation - Safety Products
Overview: This Session is a product presentation on Machine Guards -
This presentation will discuss “safety”, OSHA/ANSI requirements as they pertain to our machine guarding. Due to the pandemic, the Robotics and Automation has seen a tremendous growth in our manufacturing segment. With this said, engineers involved in manufacturing, OEM and Integrator type segments have had a growing need for guarding applications as they pertain to 29 CFR 1910 requirements
Speaker: Leo Perez | Strategic Business
Development Manager| Husky Rack and Wire
3. Electrical Safety in Manufacturing (50V-600V)
(1 PDH)
Overview:
Presenters: Howard Schwartz and John Deluzio, L3 Harris.
The Presentation will focus on the awareness of Electrical Hazards, PPE, tools and equipment, and NFPA 70E and OSHA Standard 29 CFR 1910.331-335
Speakers:
Howard Schwartz & John Deluzio L3Harris
Registration is open to anyone. You will need your NYS PE license # to register (or put N/A if not a PE). No guest registrations are allowed so you need to sign up individually!
If you need to change a session choice you will need to contact Lynne Irwin at RES, res@frontiernet.net or call and leave a message at 585-254-2350.
If you have any questions or need help contact Lynne Irwin at res@frontiernet.net or therochesterengineer@gmail (or 585-254-2350 and she will return your call).
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Jessie Cocquytres@frontiernet.net585-586-8030
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