Company profile

Qserve Group

Your MedTech Partner for Regulatory Affairs, Quality Assurance and Clinical Trials

Industry
Business Consulting and Services
Employees
85
Headquarters
Arnhem, Gelderland
Founded
1998
LinkedIn followers
9,771
Office locations
7

Qserve Group company summary

Qserve Group is a company in the Business Consulting and Services industry, headquartered in Arnhem, Gelderland, founded in 1998. On LinkedIn the company has around 85 employees and 9,771 followers. The company lists 7 office locations. Its listed specialties include Medical Device Regulatory Compliance, Medical Device Global Registration, Medical Device Clinical Evaluation, Medical Device Quality Assurance, Medical Device Auditing.

What technology does Qserve Group use?

No technologies detected yet. Warmrank rechecks company websites on a rolling basis.

About Qserve Group

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.

Specialties

Medical Device Regulatory ComplianceMedical Device Global RegistrationMedical Device Clinical EvaluationMedical Device Quality AssuranceMedical Device AuditingMedical Device TrainingMedical Device Regulatory AffairsMedical Device CROEU-MDR expertTrainingEU-IVDR expertMedical Device Registration PartnerUS FDA Compliance PartnerLocal Agent ServicesGlobal Regulatory StrategyIn Vitro DiagnosticsCompanion Diagnostics

Where is Qserve Group located?

Qserve Group lists 7 office locations.

Arnhem, Gelderland, NLHQ
Utrechtseweg 310
Boston, MA, US
One Boston Place
Farnborough, England, GB
282 Farnborough Road
Karlsruhe, Baden-Württemberg, DE
Unterreut 6
Liège, LG, BE
Quai Banning n 6
Nanjing, 210036, CN
Room 1616, Building G
Redwood City, CA, US
303 Twin Dolphin Drive

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Frequently asked questions about Qserve Group

What does Qserve Group do?

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.

How many employees does Qserve Group have?

Qserve Group has around 85 employees on LinkedIn.

Where is Qserve Group headquartered?

Qserve Group is headquartered in Arnhem, Gelderland.

Where does Qserve Group have offices?

Qserve Group lists 7 office locations, including Arnhem, Gelderland, NL; Boston, MA, US; Farnborough, England, GB; Karlsruhe, Baden-Württemberg, DE; Liège, LG, BE.

When was Qserve Group founded?

Qserve Group was founded in 1998.

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