TÜV SÜD
★★★★★
3.7
/ 5
•
312 reviews
TÜV SÜD is a leading testing, inspection, and certification company providing comprehensive medical device compliance services including importer/distributor compliance, MDR/IVDR consulting, and regulatory services. They offer both certification services and training programs for medical device manufacturers.
MedTech Europe serves as the European trade association for the medical technology industry, encompassing diagnostics, medical devices, and digital health. Their mission is to facilitate access to innovative medical technologies for more people while supporting healthcare systems in achieving sustainability. MedTech Europe actively engages with policymakers and stakeholders to promote policies that align with Europe's growing healthcare needs and expectations. They emphasize the value of medical technology through research, data, communications, industry events, and training. The association plays a crucial role in addressing key industry issues, including regulations like the EU MDR and IVDR, market access, and the advancement of digital health. They represent manufacturers and strive to foster an environment that supports innovation and responsible data use within the European Health Data Space. Founded in 2012, MedTech Europe is committed to shaping the future of healthcare by advocating for policies that enable the medical technology industry to meet evolving healthcare demands and improve patient outcomes.
About
**Who they are**
TÜV SÜD Academy (EU MDR/EUDAMED Training) is a specialized training provider focused on the European Medical Device Regulation (MDR) and EUDAMED. They offer in-depth educational programs designed for professionals in the medical technology industry.
**Expertise & scope**
- Comprehensive training on EU MDR and EUDAMED requirements.
- Focus on regulatory compliance for medical devices within the European Union.
- Programs tailored for MedTech professionals navigating complex regulatory landscapes.
**Reputation / proof points**
- Coverage: EU
- Languages: English, German
TÜV SÜD Academy (EU MDR/EUDAMED Training) is a specialized training provider focused on the European Medical Device Regulation (MDR) and EUDAMED. They offer in-depth educational programs designed for professionals in the medical technology industry.
**Expertise & scope**
- Comprehensive training on EU MDR and EUDAMED requirements.
- Focus on regulatory compliance for medical devices within the European Union.
- Programs tailored for MedTech professionals navigating complex regulatory landscapes.
**Reputation / proof points**
- Coverage: EU
- Languages: English, German
Additional information
TÜV SÜD Academy (EU MDR/EUDAMED Training) provides targeted education for navigating the EU MDR and EUDAMED. Their courses are structured to equip attendees with practical knowledge for compliance. Consider their training when preparing for regulatory submissions, audits, or when updating internal processes to align with current European medical device legislation. The academy's focus on specific regulations ensures that participants receive relevant and up-to-date information critical for market access and ongoing compliance in the EU.
Key Highlights
Certifications & Trust Signals
-
Part of TÜV SÜD, a globally recognized testing, inspection, and certification organization.
Source
“TÜV SÜD Academy”
Buyer Snapshot
Best for
- Medical device manufacturers seeking EU MDR/IVDR compliance
- Importers and distributors needing to ensure regulatory adherence
How engagement typically works
- Consultative approach to compliance
- Certification and training programs
Typical deliverables
- MDR/IVDR compliance reports
- Certification documentation
- Regulatory strategy guidance
Good to know
- Best when engaging with complex medical device regulations
HQ:
Brussels, Belgium
Languages:
English, German
Timezones:
Europe/Berlin
Status:
listed
Services & Capabilities
Importer & Distributor Compliance Support
Jurisdictions:
EU
Countries:
DE, AT, CH, FR, IT, ES, NL, BE
Industries:
Medical devices, Healthcare, Distribution
Portfolio:
26-100, 100+
Onboarding time:
7–14 days
Pricing model:
Per project
Starting from:
EUR 900
Included services:
Training for economic operator obligations, Compliance gap scan, Audit readiness support
Training Available:
Yes
Template Pack Available:
No
Deliverables:
Training
Training Format:
Live
Role Coverage:
Both
Additional importer_distributor_compliance Details
Role Coverage
Importer, Distributor, distributor
Supports MDR
true
Supports IVDR
true
Verification Support
No
Storage Conditions Support
No
Device Classes Supported
All
Onboarding Steps
No
