DNV Medical Device Services
DNV Medical Device Services provides independent certification and conformity assessment for medical products, ensuring global market access and regulatory compliance.
DNV Medical Device Services acts as a trusted Notified Body, offering comprehensive certification and conformity assessment services for medical products. They specialize in helping manufacturers achieve global market access and navigate complex regulatory landscapes, including EU MDR and IVDR compliance, MDSAP certification for multi-jurisdictional audits, and ISO 13485 for quality management systems. With a focus on safety, innovation, and regulatory adherence, DNV supports businesses in strengthening their quality systems and building confidence in the performance of their medical devices worldwide. Their services are designed to streamline market entry, reduce compliance burdens, and ensure adherence to international standards, making them a key partner for medical device companies seeking to operate globally.
About
**Who they are**
DNV Medical Device Services is an independent certification and conformity assessment provider focused on medical products. They ensure global market access and regulatory compliance for their clients.
**Expertise & scope**
* Independent certification and conformity assessment for medical products.
* Facilitating global market access.
* Ensuring regulatory compliance within the European Union.
**Reputation / proof points**
* Operates within the European Union (EU) market.
* Services are available in English.
DNV Medical Device Services is an independent certification and conformity assessment provider focused on medical products. They ensure global market access and regulatory compliance for their clients.
**Expertise & scope**
* Independent certification and conformity assessment for medical products.
* Facilitating global market access.
* Ensuring regulatory compliance within the European Union.
**Reputation / proof points**
* Operates within the European Union (EU) market.
* Services are available in English.
Additional information
DNV Medical Device Services specializes in navigating the complex regulatory landscape for medical products. Their core function is to provide independent verification and certification, which is crucial for manufacturers seeking to place their devices on the market. Clients can expect a focus on ensuring that products meet all necessary EU regulations, thereby streamlining the path to market access. The engagement is primarily conducted in English, reflecting a global approach to medical device compliance.
Key Highlights
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Provides independent certification and conformity assessment for medical products.
Source
“DNV Medical Device Services provides independent certification and conformity assessment for medical products”
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Ensures global market access and regulatory compliance for medical devices.
Source
“ensuring global market access and regulatory compliance.”
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Services cover the European Union (EU) market.
Source
“Coverage: EU”
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Services are conducted in English.
Source
“Languages: English”
Certifications & Trust Signals
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DNV is a global assurance and risk management company.
Source
“DNV Medical Device Services”
Buyer Snapshot
Best for
- Medical device manufacturers seeking EU market access.
- Companies requiring independent conformity assessment.
How engagement typically works
- Direct service provision.
- Focus on regulatory compliance and certification.
Typical deliverables
- Certification reports.
- Conformity assessment documentation.
- Guidance on EU regulatory requirements.
Good to know
- Best when clients have products intended for the EU market.
- Best when clients require independent, third-party verification.
HQ:
Oslo, Norway
Languages:
English
Timezones:
Europe/Brussels
Claim status:
Listed
Services & Capabilities
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Jurisdictions:
EU
Countries:
BE, NL, ES, DE, IE, PL, AT
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
100+
Onboarding time:
2–14 days
Pricing model:
Retainer
Starting from:
EUR 5,000
Included services:
Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration:
No
Supports UDI:
No
Supports Data Load:
No
Modules Supported:
Actor/SRN, UDI/Devices, Certificates
Supports Training Enablement:
No
Data Load Support Level:
Training only
Turnaround SLA:
Custom
Additional eudamed_reg_support Details
Included Services Detailed
Actor/SRN registration readiness review and submission support (seed scope), UDI/Device data preparation, validation, and upload workflow support (seed scope), Internal data governance mapping (roles, owners, approvals) (seed scope), Training enablement for EUDAMED operational tasks (seed scope)
Excluded Services
Notified Body services or conformity assessment decision-making, Legal representation with Competent Authorities, Clinical evaluation or performance evaluation writing (unless separately scoped)
Onboarding Steps
The provided text does not detail specific onboarding steps, required documents, timelines, or setup procedures.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
EUDAMED Registration Support
Supports Actor Registration
true
Supports UDI
true
Supports Vigilance
true
Supports Clinical Investigations
true
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