About
Our consultants are experts in Medical Device Quality Systems (FDA CGMP / 21CFR – Part 820 QSR, ISO 13485:2016), EU MDR 2017/745, Design Controls for New Products, Risk Management (ISO 14971:2012), Validations, Quality Engineering, Quality System Auditing, Supplier audits, Quality management and remediation.
Technologies
Google Cloud Hosting
Varnish
Mobile Friendly
Wix
Keywords
gmps
test method validation
fda
audits
quality control
risk management
new product introduction
complaint handling
software quality
eu mdr
engineering
project management
reliability
remediation planning & execution
medical device
quality sytems
supplier quality
capa
design controls
iso 1385
validation
auditing
productivity
hospital & health care
Company Information
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Employees 1
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Founded 2014
