Medical Design Briefs - January 2022 - 20

Establishing Proper Validation of
Extruded Silicone Tubing
M
20
Cov
edical device manufacturers
understand that
contract manufacturers
are experts in their manufacturing
discipline.
That said, as medical device OEMs
respond to the current requirements
described in the European Medical
Device Regulation (EU MDR) or by the
Food and Drug Adminstration (FDA),
the topic of process validation is more
and more common. Most OEMs simply
don't have a validation plan for a contract
manufacturer to follow. While engineers
are fully aware that it's a requirement
for releasing their product in the
market, many simply want to " check the
box " that this has been completed. This
article presents a program that moves
projects from the process development
phase of manufacturing to a fully validated
process.1,2
www.medicaldesignbriefs.com
ToC
Prior to jumping into a validation discussion,
it makes sense to address the
difference between verification and validation.
Verification is typically performed
while a product or process is
being developed. It is a means by which
to determine whether a product (or
process) meets the dimensional or visual
requirements set forth by the product
specification. FDA 21 CFR part
820.75(a) stipulates that if process
Medical Design Briefs, January 2022
Credit: SiMEDEx
http://www.medicaldesignbriefs.com http://info.hotims.com/82317-803

Medical Design Briefs - January 2022

Table of Contents for the Digital Edition of Medical Design Briefs - January 2022

Medical Design Briefs - January 2022 - Intro
Medical Design Briefs - January 2022 - Sponsor
Medical Design Briefs - January 2022 - Cov1a
Medical Design Briefs - January 2022 - Cov1b
Medical Design Briefs - January 2022 - Cov1
Medical Design Briefs - January 2022 - Cov2
Medical Design Briefs - January 2022 - 1
Medical Design Briefs - January 2022 - 2
Medical Design Briefs - January 2022 - 3
Medical Design Briefs - January 2022 - 4
Medical Design Briefs - January 2022 - 5
Medical Design Briefs - January 2022 - 6
Medical Design Briefs - January 2022 - 7
Medical Design Briefs - January 2022 - 8
Medical Design Briefs - January 2022 - 9
Medical Design Briefs - January 2022 - 10
Medical Design Briefs - January 2022 - 11
Medical Design Briefs - January 2022 - 12
Medical Design Briefs - January 2022 - 13
Medical Design Briefs - January 2022 - 14
Medical Design Briefs - January 2022 - 15
Medical Design Briefs - January 2022 - 16
Medical Design Briefs - January 2022 - 17
Medical Design Briefs - January 2022 - 18
Medical Design Briefs - January 2022 - 19
Medical Design Briefs - January 2022 - 20
Medical Design Briefs - January 2022 - 21
Medical Design Briefs - January 2022 - 22
Medical Design Briefs - January 2022 - 23
Medical Design Briefs - January 2022 - 24
Medical Design Briefs - January 2022 - 25
Medical Design Briefs - January 2022 - 26
Medical Design Briefs - January 2022 - 27
Medical Design Briefs - January 2022 - 28
Medical Design Briefs - January 2022 - 29
Medical Design Briefs - January 2022 - 30
Medical Design Briefs - January 2022 - 31
Medical Design Briefs - January 2022 - 32
Medical Design Briefs - January 2022 - 33
Medical Design Briefs - January 2022 - 34
Medical Design Briefs - January 2022 - 35
Medical Design Briefs - January 2022 - 36
Medical Design Briefs - January 2022 - 37
Medical Design Briefs - January 2022 - 38
Medical Design Briefs - January 2022 - 39
Medical Design Briefs - January 2022 - 40
Medical Design Briefs - January 2022 - Cov3
Medical Design Briefs - January 2022 - Cov4
https://www.nxtbook.com/smg/techbriefs/22MDB06
https://www.nxtbook.com/smg/techbriefs/22MDB04
https://www.nxtbook.com/smg/techbriefs/techleaders21
https://www.nxtbook.com/smg/techbriefs/22MDB03
https://www.nxtbook.com/smg/techbriefs/22MDB02
https://www.nxtbook.com/smg/techbriefs/22MDB01
https://www.nxtbook.com/smg/techbriefs/21MDB12
https://www.nxtbook.com/smg/techbriefs/21MDB11
https://www.nxtbook.com/smg/techbriefs/21MDB10
https://www.nxtbook.com/smg/techbriefs/21MDB09
https://www.nxtbook.com/smg/techbriefs/21MDB08
https://www.nxtbook.com/smg/techbriefs/21MDB07
https://www.nxtbook.com/smg/techbriefs/21MDB06
https://www.nxtbook.com/smg/techbriefs/21MDB05
https://www.nxtbook.com/smg/techbriefs/21MDB04
https://www.nxtbook.com/smg/techbriefs/21MDB02
https://www.nxtbookmedia.com