Qserve is a trusted global partner for MedTech Regulatory, Clinical, and Quality Compliance, as well as a full-service CRO for medical device clinical trials.
With a strong international presence in Europe, China, and the United States, our team of experts combines deep regulatory knowledge with hands-on industry experience to help manufacturers achieve global market access for all types of medical devices and in vitro diagnostics (IVDs).
We provide strategic guidance and tailored support across a wide range of services, including:
- Regulatory Affairs. EU MDR, EU IVDR, FDA compliance, global regulatory strategy, CE marking, Pre-IDE, PMA, 510(k) submissions, and global medical device registration.
- Clinical Affairs & CRO Services. Clinical trial design and execution, clinical evaluations, post-market clinical follow-up, and regulatory due diligence.
- Quality & Compliance. Quality management system implementation, gap analysis, audits, and training.
- Global Representation. US Agent, EU Representative, UK Responsible Person, and China Agent for NMPA registration.
Whether you're navigating complex regulatory landscapes, optimizing clinical strategies, or ensuring compliance, Qserve is your dedicated partner in bringing innovative MedTech solutions to market.
Company Details
- Employees
- 85
- Founded
- -
- Address
- Utrechtseweg 310, Business Park Arnhem,building 42,belgium
- Phone
- 1(603)369-3550
- in****@****oup.com
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- qservegroup.com
- Keywords
- Medical Device Regulatory Compliance, Medical Device Global Registration, Medical Device Clinical Evaluation, Medical Device Quality Assurance, Medical Device Auditing, Medical Device Training, Medical Device Regulatory Affairs, Medical Device CRO, EU-MDR expert, Training, EU-IVDR expert, Medical Device Registration Partner, US FDA Compliance Partner, Local Agent Services, Global Regulatory Strategy, In Vitro Diagnostics, Companion Diagnostics.
- HQ
- Arnhem, Gelderland
Qserve Group Questions
Qserve Group's helpline number is 1(603)369-3550
Qserve Group's website is qservegroup.com
Qserve Group's LinkedIn profile is https://www.linkedin.com/company/qserve-group
Qserve Group has
85 employees.
View email and phone details for 85
employees at Qserve Group.
Qserve Group's industry is
Business Consulting and Services
Qserve Group's top competitors are
Emergo By Ul,
Qserve It Solutions,
Pro-Liance Global Solutions Gmbh,
Johner Institut Gmbh,
Rqm+,
Regulatory Affairs Professionals Society (Raps),
Evnia,
Medenvoy Global,
Namsa,
Bsi.
Qserve Group's support email address is info@qservegroup.com
Qserve Group's categories are Business Consulting and Services
Qserve Group's founding year is 1998
