Qserve Group
Qserve Group is a global MedTech partner specializing in Regulatory Affairs, Quality Assurance, and Clinical Trials. They help medical device and IVD manufacturers navigate complex regulations for market access and compliance worldwide.
Qserve Group, founded in 1998, is a well-established global player in the medical device industry, offering expert support across the entire product lifecycle. They specialize in Regulatory Affairs, Quality Assurance, and Clinical Trials, assisting manufacturers with market access, approvals, and maintaining regulatory compliance. With a practical approach, Qserve balances business needs with regulatory requirements. Their team of experienced professionals, many with backgrounds in the MedTech industry or from notified bodies, provides implementation-ready advice. They offer services including CE marking, FDA submissions, Quality Management Systems, clinical evaluations, and audits. Qserve's mission is to improve patient safety and health by supporting the advancement of biomedical technology. They are committed to helping medical device and in-vitro diagnostics manufacturers worldwide achieve and maintain regulatory compliance, ensuring life-changing devices reach those who need them most.
About
**Who they are**
Qserve Group, founded in 1998, is a global MedTech partner specializing in Regulatory Affairs, Quality Assurance, and Clinical Trials. They assist medical device and in-vitro diagnostics manufacturers worldwide with market access and regulatory compliance.
**Expertise & scope**
* Navigating complex EU regulations, including MDR and IVDR, for market access and compliance.
* Providing strategic support for classification, documentation, and conformity assessment.
* Acting as an EU Authorized Representative for non-EU manufacturers.
* Offering expertise in clinical evidence, traceability, post-market surveillance, and technical documentation.
* Supporting CE marking and coordination with Notified Bodies.
* Assisting with country-specific registration requirements within the EU.
* Providing support across the entire product lifecycle, from development to post-market activities.
**Reputation / proof points**
* Founded in 1998, with significant experience in the MedTech industry.
* Consultants often have backgrounds from the MedTech industry, including roles in regulatory, quality, clinical, R&D, or employment by notified bodies.
* Recognized for a practical approach, balancing business needs with regulatory compliance.
Qserve Group, founded in 1998, is a global MedTech partner specializing in Regulatory Affairs, Quality Assurance, and Clinical Trials. They assist medical device and in-vitro diagnostics manufacturers worldwide with market access and regulatory compliance.
**Expertise & scope**
* Navigating complex EU regulations, including MDR and IVDR, for market access and compliance.
* Providing strategic support for classification, documentation, and conformity assessment.
* Acting as an EU Authorized Representative for non-EU manufacturers.
* Offering expertise in clinical evidence, traceability, post-market surveillance, and technical documentation.
* Supporting CE marking and coordination with Notified Bodies.
* Assisting with country-specific registration requirements within the EU.
* Providing support across the entire product lifecycle, from development to post-market activities.
**Reputation / proof points**
* Founded in 1998, with significant experience in the MedTech industry.
* Consultants often have backgrounds from the MedTech industry, including roles in regulatory, quality, clinical, R&D, or employment by notified bodies.
* Recognized for a practical approach, balancing business needs with regulatory compliance.
Additional information
Qserve Group emphasizes a practical approach, drawing from consultants with direct industry experience. This allows them to provide advice that is grounded in operational reality. For manufacturers outside the EU, engaging an EU Authorized Representative is a legal requirement to ensure compliance and serve as the primary contact with EU authorities. Their services are designed to facilitate efficient market access and long-term compliance within the European Union, particularly under the complex MDR and IVDR frameworks. They guide clients through CE certification processes, including necessary coordination with Notified Bodies and addressing individual member state registration requirements.
Key Highlights
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Founded in 1998, Qserve Group brings over two decades of experience in MedTech regulatory affairs and quality assurance.
Source
“Qserve Group was founded in 1998 and started with a small group of regulatory experts.”
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Specializes in navigating the complexities of EU MDR and IVDR regulations for market access.
Source
“As a medtech manufacturer, you know that gaining access to the European market under MDR (for medical devices) or IVDR (for in vitro diagnostics) is more complex than ever.”
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Acts as an EU Authorized Representative for non-EU manufacturers, ensuring compliance and acting as a point of contact with EU authorities.
Source
“For non-EU manufacturers, an EU Authorized Representative is legally required to ensure compliance and act as the main point of contact with EU authorities.”
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Consultants often possess practical, industry-based experience, having worked in regulatory, quality, clinical, or R&D roles within the MedTech sector.
Source
“many of our consultants come from the MedTech industry, often having worked in regulatory, quality, clinical, or R&D roles”
Certifications & Trust Signals
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Established in 1998, providing regulatory and quality assurance services for over two decades.
Source
“Qserve Group was founded in 1998”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking EU market access.
- Companies needing assistance with MDR and IVDR compliance.
- Non-EU manufacturers requiring an EU Authorized Representative.
How engagement typically works
- Partnership approach with a practical focus.
- Strategic guidance and hands-on support.
- Project-based support or interim staffing solutions.
Typical deliverables
- EU Authorized Representative services.
- Regulatory strategy and documentation support.
- CE marking and conformity assessment guidance.
- Post-market surveillance and vigilance support.
Good to know
- Best when requiring specialized regulatory expertise for complex medical device and IVD markets.
HQ:
Arnhem, NL
Languages:
English, Dutch
Timezones:
Europe/Amsterdam
Status:
listed
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU
Countries:
NL, BE, DE, FR, IE, SE
Industries:
Medical devices, IVD, Healthcare
Portfolio:
26-100, 100+
Onboarding time:
3–21 days
Pricing model:
Retainer
Starting from:
EUR 6,500
Included services:
EU Authorized Representative (EC REP) designation, Authority liaison and document availability support, Vigilance escalation and FSCA coordination, Labeling/EC REP identification review, Post-market support workflows (complaints, vigilance escalation)
Supports MDR:
Yes
Supports IVDR:
Yes
Post Market Support:
Yes
EU Entity Country:
Netherlands
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
Labeling Review:
Yes
Fsca Recall Support:
Yes
Additional eu_ar Details
Device Classes Supported
All device classes supported under MDR/IVDR
Supports MDR
Yes
Supports IVDR
Yes
EU Entity Country
NL
Fsca Recall Support
Implied through post-market surveillance and vigilance support
Post Market Support
Yes
Vigilance Contact Support
Yes
Onboarding Steps
Engage with Qserve Group to discuss needs, complete a form, and expect contact within one business day to discuss possibilities.
