Personal Information
Organization / Workplace
Indianapolis, IN United States
Industry
Technology / Software / Internet
Website
greenlight.guru
About
Greenlight Guru produce beautifully simple quality management software exclusively for medical device companies.
Tags
medtech
medical device
regulatory
medical devices
regulations
quality
life sciences
quality management
quality system
risk management
risk
medical device industry
risk based
qms
fda
compliance
software
covid-19
quality management system
audit
iso 13485
product development
eu mdr
design controls
fda inspections
iso 13485:2016
mdr
iso
ppe
biotech
remote
ivdr
engineering
europe
fda 510(k)
biotechnology
iso 14971
pandemic
eua
pms
brexit
testing
standards
mdsap
capa
prediction
iec 60601-1
medical
medical device reporting
emdr
samd
notified bodies
latin america
israel
usability engineering
human factors
qmsr
unique device identification
udi
swexit
machine learning
artificial intelligence
digital health
fda guidance documents
leadership
remote work
fda emergency order
value
healthcare
ce mark
post-market surveillance
post marketing quality processes
manufacturing solutions
post market surveillance
ivdd
in vitro diagnostics regulation
risk assessment
toxicological
e&l
extractable and leachable
manufacturing
turkxit
swixit
fda regulations
human factors engineering
hfe
ui
ux
user experience design
user experience
product definition
documentation
project development
design validation
validation
medical device data
connected medical device
cloud
cloud connectivity
process
startup
q-submissions
pre-sub meetings
benchmark
impact
saas
fda case for quality
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eqms
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med tech
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in vitro diagnostics
medical electrical standards
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de novo pathway
quality managementr
complaints
design transfer
single audit program
qsr
pma
liability
mitigation
management
clinical evaluation
meddev
design control
product management
startups
document management
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