S
Susan
Vp International Regulatory Affairs at Qserve
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Work Experience
Vp International Regulatory Affairs
2006 - Present · 18 years and 11 months
Company Details
51-200 Employees
Qserve is your global partner for Medtech Regulatory, Clinical & Quality Compliance and your CRO for Medical Device Clinical Trials. With our broad range of knowledge and experience, we can support you with getting market access all over the world and for all kind of Medical Devices and In Vitro Diagnostics. Our strong international team, located in Europe, China and the United States, combines their broad range of knowledge and expertise in medical devices and IVDs, to assist manufacturers in gaining market access around the world. Qserve’s in-house consultants advise in numerous areas, including Regulatory Affairs, EU-MDR, EU-IVDR, FDA Compliance, Global Regulatory Strategy, Clinical Affairs, CRO, Strategic Planning, Due Diligence & GAP analysis, CE-Marking, Pre-IDE, PMA, 510(k) Submissions, us Agent, EU representative, UK RP, China Agent, NMPA Registration, Global Medical Device Registration, Trainings & Quality Management Systems implementation. Your Global MedTech Partner for Regulatory Affairs, Quality Assurance and Clinical Trials. Your global CRO for Medical Device Clinical Trials
Year Founded
1998
Social Media
Linkedin
Industry
Business Consulting and Services, Consultants
HQ Location
Utrechtseweg 310 Business Park Arnhem, Building 42 Arnhem, Gelderland 6812 AR, NL
Keywords
Medical Device Regulatory ComplianceMedical Device Global RegistrationMedical Device Clinical EvaluationMedical Device Quality AssuranceMedical Device AuditingMedical Device TrainingMedical Device Regulatory AffairsMedical Device CROEU-MDR expertTraining
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