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 device classification, technical documentation, and conformity assessment.
* Acting as an EU Authorized Representative for non-EU manufacturers, serving as the primary contact with EU authorities.
* Offering practical, implementation-ready advice grounded in operational reality, drawing from consultants with backgrounds in the MedTech industry and notified bodies.
* Supporting the entire product lifecycle, from development to post-market activities, including CE marking and FDA submissions.
**Reputation / proof points**
* Founded in 1998, with significant experience in MedTech regulatory affairs.
* Operates with a practical approach, balancing business needs and regulatory compliance.
* Employs a diverse global team of professionals with a shared passion for medical device technology and high standards of quality and competence.
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 device classification, technical documentation, and conformity assessment.
* Acting as an EU Authorized Representative for non-EU manufacturers, serving as the primary contact with EU authorities.
* Offering practical, implementation-ready advice grounded in operational reality, drawing from consultants with backgrounds in the MedTech industry and notified bodies.
* Supporting the entire product lifecycle, from development to post-market activities, including CE marking and FDA submissions.
**Reputation / proof points**
* Founded in 1998, with significant experience in MedTech regulatory affairs.
* Operates with a practical approach, balancing business needs and regulatory compliance.
* Employs a diverse global team of professionals with a shared passion for medical device technology and high standards of quality and competence.
Additional information
For manufacturers outside the EU, appointing an EU Authorized Representative is a legal requirement to ensure compliance and facilitate communication with EU authorities. Qserve Group's expertise in MDR and IVDR means they can guide companies through the intricate requirements for CE certification and subsequent market entry across all 27 EU member states. Their practical approach, informed by consultants with direct industry and notified body experience, helps streamline the process, minimizing delays and risks associated with market access.
Key Highlights
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Founded in 1998, Qserve Group brings extensive experience to MedTech regulatory affairs.
Source
“Qserve Group was founded in 1998 and started with a small group of regulatory experts.”
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Specializes in navigating complex 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.
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 come from the MedTech industry or have worked with notified bodies, ensuring practical advice.
Source
“many of our consultants come from the MedTech industry, often having worked in regulatory, quality, clinical, or R&D roles or having been employed by notified bodies.”
Certifications & Trust Signals
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Established in 1998, demonstrating long-term presence and experience in the MedTech regulatory field.
Source
“Qserve Group was founded in 1998”
Buyer Snapshot
Best for
- Non-EU medical device and IVD manufacturers seeking EU market access.
- Companies needing assistance with MDR and IVDR compliance.
How engagement typically works
- Project-based support
- Strategic advice
- Interim staffing solutions
Typical deliverables
- EU Authorized Representative services
- Regulatory strategy and documentation support
- CE marking guidance
- Post-market surveillance support
Good to know
- Best when requiring expert navigation of complex EU medical device regulations.
HQ:
Arnhem, NL
Languages:
English, Dutch
Timezones:
Europe/Amsterdam
Claim 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
Supports MDR
Yes
Supports IVDR
Yes
EU Entity Country
NL
Fsca Recall Support
Yes
Post Market Support
Yes
Vigilance Contact Support
Yes
Onboarding Steps
Onboarding involves discussing needs to understand possibilities and achieve goals efficiently and compliantly. Contact is made within one business day after form submission.
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