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 body.
**Expertise & scope**
* Provides services to ensure global market access for medical products.
* Focuses on regulatory compliance for medical devices.
* Offers independent certification and conformity assessment.
**Reputation / proof points**
* Operates within the European Union (EU) market.
DNV Medical Device Services is an independent certification and conformity assessment body.
**Expertise & scope**
* Provides services to ensure global market access for medical products.
* Focuses on regulatory compliance for medical devices.
* Offers independent certification and conformity assessment.
**Reputation / proof points**
* Operates within the European Union (EU) market.
Additional information
DNV Medical Device Services focuses on providing independent certification and conformity assessment for medical products. Their services are designed to facilitate global market access and ensure adherence to regulatory compliance standards. Buyers engaging with DNV Medical Device Services can expect a focus on the rigorous assessment of medical devices to meet international requirements. The organization operates within the European Union, indicating a strong understanding of EU regulatory landscapes.
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.”
-
Coverage focused on the European Union (EU).
Source
“Coverage: EU”
Certifications & Trust Signals
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Operates as an independent certification and conformity assessment body.
Source
“DNV Medical Device Services provides independent certification and conformity assessment”
Buyer Snapshot
Best for
- Medical device manufacturers seeking EU market access
- Companies requiring independent conformity assessment
How engagement typically works
- Certification and assessment services
- Regulatory compliance support
Typical deliverables
- Certification reports
- Conformity assessment documentation
Good to know
- Best when requiring formal certification and compliance validation for medical devices within the EU.
HQ:
Oslo, Norway
Languages:
English
Timezones:
Europe/Brussels
Status:
listed
Services & Capabilities
Best EUDAMED Registration| Compare & Get Quotes
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:
Yes
Supports UDI:
Yes
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 provider offers support for Actor/SRN and UDI/Device data workflows, implying a structured process for these registrations.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
Actor, UDI/Devices
Supports Actor Registration
false
Supports UDI
false
Supports Vigilance
false
Supports Clinical Investigations
false
