About
MDS Denmark is providing services for medical device companies and start-ups. Our core competence is to: Build up and maintain Quality Management Systems Handle device market access (e.g. CE and FDA) Function as a CRO and plan clinical trials Compile design dossiers Write clinical evaluations Plan logistics and supplier network Offer outsourced Quality Director
Technologies
Gmail
Google Apps
Mobile Friendly
Apache
Google Font API
WordPress.org
Keywords
medical equipment manufacturing
regulatory strategy
regulatory consulting
project management
medical devices
conformity assessment procedure
iso 13485
clinical research
services
market analysis
project management cro
medical device consulting
intended use analysis
market entry strategy
eu ce marking
eu mdr
auditing services
clinical evaluation reports
risk management
consulting
regulatory pathway
european authorized representative
fda approval process
medical device testing
person responsible for regulatory compliance (prrc)
post-market surveillance (pms)
quality management systems
regulatory compliance
biological evaluation reports (ber)
technical files
Company Information
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Employees 1
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Founded 2024
Location
76 Njalsgade, Copenhagen, Capital Region of Denmark, Denmark, 2300
