About
Consultants for WHO-PQ, WHO-EUL & QMS (ISO13485) & Regulatory (CDSCO MDR 2017, EU, USFDA, MDSAP). Medical Device & IVD Intrust started consultancy amidst changing regulation (MDR 2017, EU MDR & IVDR, MDSAP) requiring highest level of compliance to ISO 13485 based QMS from Design to Post Market Surveillance and other regulatory targets. This means improved quality of people, products and processes which can sustain stringent & unannounced audits. Even notified bodies are re-qualified for this purpose.
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Keywords
medical equipment manufacturing
mdr 745 & ivdr 746 compliance
post-market surveillance
medical devices
medical device regulation
medical equipment and supplies manufacturing
clinical investigation
mdsap
consulting
ce marking
clinical performance evaluation
technical documentation
regulatory compliance
b2b
cdsco mdr 2017
manufacturing
medical device industry
design verification & validation
smart qms
regulatory consultancy
risk management
qms implementation
iso 13485
healthcare
quality management system design
product lifecycle compliance
services
global regulatory standards
hospital & health care
mechanical or industrial engineering
Company Information
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Employees 2
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Founded 2020
Location
New Delhi, Delhi, India, 110001
