About
Passionate experts in MedTech for more than 20 years, we support Swiss and French SMEs and start-ups on the (sometimes) steep path of placing or keeping medical devices on the market. Our services: - Support in the START-UP/development phase - Clinical Evaluation Report, Biological Risk Assessment report - ISO 13485/RDM/MDSAP Conformity, including audits
Technologies
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Keywords
bra
iso10993
medical device
mdsap
notified body
pmcf
iso14971
cer
technical file
gap analysis
quality system
startup
ce marking
medtech
iso13485
mdr
post market suirveillance
mdd
meddev 271
medical equipment manufacturing
clinical data analysis
regulatory gap analysis
testing laboratories and services
healthcare analytics
regulatory strategy
regulatory compliance
b2b
audits
medical device regulation
risk assessment
Company Information
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Employees 3
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Founded 2019
Location
Avenue de France, Geneva, Geneva, Switzerland, 1202
