BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T120328Z UID:7425d9af-bfc4-4f82-b8a7-ebd47abb4a09 DTSTART:20210301T130000 DTEND:20210302T130000 CLASS:PRIVATE DESCRIPTION:
Overview
\n\nThe U.S. Food and Drug A
dministration (FDA) is responsible for regulating the development of and m
anufacturing processes for medical devices. The FDA also determines the ne
cessary requirements before these medical devices can hit the markets. It&
rsquo\;s crucial that FDA design controls are strictly followed in the pro
cess of product development.
\n
\nHowever\, designing a medical
device and testing it to prove that it works is not sufficient in the eyes
of the FDA to provide a safe product for users. Medical device designers\
, developers\, engineers and manufacturers must be intimately familiar wit
h the FDA&rsquo\;s requirements that ensure a product is safe for use befo
re it reaches the markets.
\n
\nIn this Virtual Boot Camp\, Edwi
n Waldbusser will guide you on how to comply with the FDA&rsquo\;s require
ments for designing and testing a medical device.
 \ ;
\n\n \;
\n\nSession Objectives
\n\n< ul>\nWhat is design control?
\nWhen does it start?
\nWhy hazard analysis following ISO14971 i s the best risk control method
\nHuman factors follo wing new FDA guidance and ISO 62366
\nWhy software v alidation is more than testing
\n\n \;
\nSession Details
\n\nSession 1: De sign Control
\n\nLength: 60 minutes
\n\ nThe FDA has determined\, through analysis of product recall data\, tha t the majority of recalls were due to a faulty design process\, not faulty manufacturing. These recalled products were tested before release and lat er failed in unanticipated ways that were not considered in the design and testing process. According to the FDA\, the factors resulting in the desi gn process that will reduce the chances of an unsafe product include: a we ll-controlled design process with risk analysis\, change control\, design reviews\, human factors analysis\, hardware/software validation and feedba ck of the risk analysis results into the design process.
\n\nThis se
ssion will answer the important and confusing question of when design cont
rol begins in a development process. The session will explain the differen
ce between pre-release and post-release change control. Edwin will further
explain the design history file and will discuss a contents checklist. He
will also explain the interrelationship between ongoing risk analysis and
the design process. \;
\n
\nSession Highlights:&nbs
p\;
Session-2: Hazard Analysis
\n\nLength: 60 minutes
\n\nThe FDA expect s that risk management will be conducted as a part of a product developmen t program. The agency recommends using ISO 14971 as a guide and has accept ed it as a recognized standard. Hazard analysis is the most powerful of th e risk management tools described in ISO 14971\; however\, it can be very confusing.
\n\nMany new concepts have been introduced. This session
will explain these new concepts and will provide you with examples so that
the process is clear. One of the techniques described in ISO 14971 is haz
ard analysis\, which is the most powerful of the risk management technique
s because it considers risks in normal operation as well as fault conditio
ns. FMEA and FTA consider only fault conditions and are more suited as rel
iability tools than as product safety tools. \;
\n
\nIn this
session\, Edwin will explain in detail the process of conducting a hazard
analysis. It will explain confusing terms like &ldquo\;hazard\,&rdquo\; h
azardous situation\,&rdquo\; &ldquo\;harm\,&rdquo\; &ldquo\;causative even
t\,&rdquo\; &ldquo\;ALARP\,&rdquo\; &ldquo\;risk index&rdquo\; and &ldquo\
;residual risk.&rdquo\; \;
\n
\nSession Highlights:&
nbsp\;
Length: 60 minute s
\n \;
\n\nWho Will Benefit< /p>\n\n
Medical Device Engineering Personnel
\nMedical device designers
\nR&\;D
\nQA / RA
\nSoftware Developers
\nManufacturing
\nOperations
\ nMid- and Senior-level Management
\nCEOs and CFOs
\nSales and Marketing
\nPurchasing
\nOther Medical Products Manuf acturing Stakeholders
\n