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
GmailGoogle AppsMobile FriendlyApacheGoogle Font APIWordPress.org
Keywords
medical equipment manufacturingregulatory strategyregulatory consultingproject managementmedical devicesconformity assessment procedureiso 13485clinical researchservicesmarket analysisproject management cromedical device consultingintended use analysismarket entry strategyeu ce markingeu mdrauditing servicesclinical evaluation reportsrisk managementconsultingregulatory pathwayeuropean authorized representativefda approval processmedical device testingperson responsible for regulatory compliance (prrc)post-market surveillance (pms)quality management systemsregulatory compliancebiological evaluation reports (ber)technical files
Company Information
- Employees1
- Founded2024
Location
76 Njalsgade, Copenhagen, Capital Region of Denmark, Denmark, 2300