TÜV NORD Akademie – Medical Device Trainings
TÜV NORD AG
★★★★★
4.4
/ 5
•
126 reviews
TÜV NORD Akademie offers specialized medical device training and regulatory support for the EU MDR and IVDR, ensuring compliance and market access.
TÜV NORD Akademie is a leading provider of specialized training and certification services, with a focus on medical device regulations. They offer comprehensive support for navigating complex regulatory landscapes, including EU MDR and IVDR compliance, crucial for market access in the European Union. Their expertise extends to various industries, providing services such as audits, certifications, and technical assessments. The TÜV NORD GROUP is committed to knowledge sharing, offering a wealth of information through their knowledge portal, including articles, podcasts, and updates on certification trends. With a strong emphasis on quality and compliance, TÜV NORD Akademie empowers businesses to meet stringent regulatory requirements and achieve their market objectives. They are dedicated to fostering expertise and ensuring that professionals in the medical device sector are well-equipped to handle the evolving demands of the industry.
About
**Who they are**
TÜV NORD Akademie – Medical Device Trainings provides specialized training and regulatory support for medical device manufacturers navigating EU regulations.
**Expertise & scope**
* Offers training focused on the EU MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation).
* Ensures compliance and facilitates market access for medical devices within the European Union.
* Provides regulatory support services tailored to the medical device industry.
**Reputation / proof points**
* Coverage across the EU.
TÜV NORD Akademie – Medical Device Trainings provides specialized training and regulatory support for medical device manufacturers navigating EU regulations.
**Expertise & scope**
* Offers training focused on the EU MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation).
* Ensures compliance and facilitates market access for medical devices within the European Union.
* Provides regulatory support services tailored to the medical device industry.
**Reputation / proof points**
* Coverage across the EU.
Additional information
TÜV NORD Akademie – Medical Device Trainings focuses on equipping professionals with the knowledge required for EU MDR and IVDR compliance. Their training programs are designed to address the complexities of these regulations, aiming to streamline the process for obtaining and maintaining market access. Buyers can expect a structured approach to understanding regulatory requirements and implementing necessary compliance measures.
Key Highlights
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Specializes in EU MDR and IVDR training and regulatory support.
Source
“TÜV NORD Akademie offers specialized medical device training and regulatory support for the EU MDR and IVDR”
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Supports compliance and market access for medical devices in the EU.
Source
“ensuring compliance and market access.”
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Provides training and support in English and German.
Source
“Languages: English, German”
Certifications & Trust Signals
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Operates within the European Union market.
Source
“Coverage: EU”
Buyer Snapshot
Best for
- Medical device manufacturers seeking EU MDR and IVDR compliance training.
- Companies needing regulatory support for EU market access.
How engagement typically works
- Training programs
- Regulatory support services
Typical deliverables
- Enhanced understanding of EU MDR/IVDR
- Guidance on compliance strategies
- Support for market access procedures
Good to know
- Best when focused on EU regulatory requirements for medical devices.
HQ:
Hannover, DE
Languages:
English, German
Timezones:
Europe/Brussels
Status:
listed
Services & Capabilities
Best EUDAMED Registration| Compare & Get Quotes
Jurisdictions:
EU
Countries:
DE, PL, SE, DK, BE, IT
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
100+
Onboarding time:
1–10 days
Pricing model:
Per project
Starting from:
EUR 750
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:
Yes
Modules Supported:
Actor/SRN, UDI/Devices, Certificates, Vigilance
Supports Training Enablement:
Yes
Data Load Support Level:
Done-for-you
Turnaround SLA:
3-7 days
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
Onboarding involves understanding specific training needs related to EU MDR and IVDR compliance. The process is designed to equip professionals with practical knowledge for regulatory adherence and market access.
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, Vigilance, Clinical Investigations, Certificates & Notifications
Supports Actor Registration
Yes
Supports UDI
Yes
Supports Vigilance
Yes
Supports Clinical Investigations
Yes
