European Authorized Representative - VISAMED
VISAMED GmbH
VISAMED is a specialized consulting company providing regulatory affairs and quality management services for medical devices. They offer expertise in EU Authorized Representative services, product approval, QMS adaptation, and software validation.
VISAMED GmbH is a highly specialized consulting company offering a full range of services to medical device companies worldwide. With an experienced and dedicated professional team, they focus on medical device regulation, quality systems, and product development. As an EU Authorized Representative, VISAMED assists companies in navigating regulatory requirements for their medical devices. Their core services include Risk Management & Usability, Clinical Evaluation, Software Validation, QMS implementation, and Interim Management. They also provide support for Mobile Apps development, from concept to regulatory approval. VISAMED is committed to helping clients adapt their QM-Systems to comply with regulatory requirements and get their medical devices approved in key markets like Europe, Canada, and the US. Located in Karlsruhe, Germany, VISAMED's expertise extends to verifying and validating software and assisting with localization. They are a valuable partner for companies seeking comprehensive regulatory and quality management support in the medical device industry.
About
**Who they are**
European Authorized Representative - VISAMED is a specialized consulting company based in Karlsruhe, Germany, focusing on regulatory affairs and quality management for medical devices. They offer expertise in EU Authorized Representative services.
**Expertise & scope**
- EU Authorized Representative services
- Product approval
- QMS adaptation
- Software validation
- Risk Management & Usability
- Clinical Evaluation
- Interim Management
- Mobile Apps + Apps Development
**Reputation / proof points**
- Registered Office: Karlsruhe
- Managing Director: Dipl. Ing. (FH) MBA Arne Briest
- Commercial Register: Amtsgericht Mannheim, HRB 733623
- Sales tax identification number: DE325035614
European Authorized Representative - VISAMED is a specialized consulting company based in Karlsruhe, Germany, focusing on regulatory affairs and quality management for medical devices. They offer expertise in EU Authorized Representative services.
**Expertise & scope**
- EU Authorized Representative services
- Product approval
- QMS adaptation
- Software validation
- Risk Management & Usability
- Clinical Evaluation
- Interim Management
- Mobile Apps + Apps Development
**Reputation / proof points**
- Registered Office: Karlsruhe
- Managing Director: Dipl. Ing. (FH) MBA Arne Briest
- Commercial Register: Amtsgericht Mannheim, HRB 733623
- Sales tax identification number: DE325035614
Additional information
VISAMED provides a range of services beyond just EU Authorized Representative functions. Their expertise extends to critical areas such as Risk Management & Usability, Clinical Evaluation, and Software Validation, which are essential for navigating the complex regulatory landscape of medical devices. They also offer support for QMS adaptation and interim management roles, indicating a comprehensive approach to regulatory and quality compliance for their clients.
Key Highlights
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Specializes in EU Authorized Representative services for medical devices.
Source
“EU Authorized Representative”
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Offers expertise in product approval, QMS adaptation, and software validation.
Source
“QMS Software Validation”
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Provides services including Risk Management & Usability and Clinical Evaluation.
Source
“Risk Management & Usability Clinical Evaluation”
Certifications & Trust Signals
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Registered office in Karlsruhe, Germany.
Source
“Registered Office: Karlsruhe”
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Commercial Register details: Amtsgericht Mannheim, HRB 733623.
Source
“Commercial Register: Amtsgericht Mannheim, HRB 733623”
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Sales tax identification number: DE325035614.
Source
“Sales tax identification number according to § 27 a of the Sales Tax Law: DE325035614”
Buyer Snapshot
Best for
- Medical device manufacturers seeking EU Authorized Representative services
- Companies needing support with product approval and QMS adaptation
- Businesses requiring expertise in software validation for medical devices
How engagement typically works
- Consulting services for regulatory affairs
- Quality management support
- Specialized expertise in EU MDR/IVDR compliance
Typical deliverables
- EU Authorized Representative appointment
- Regulatory strategy and submission support
- Quality Management System documentation and implementation
- Software validation reports
Good to know
- Best when clients require specialized regulatory and quality management support for medical devices within the EU market.
HQ:
Karlsruhe, DE
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU
Countries:
EU
Industries:
Medical Devices, Pharmaceuticals, Biotech
Onboarding time:
7–21 days
Pricing model:
Custom pricing
Alternate Names:
VISAMED GmbH
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
Post Market Support:
Yes
Labeling Review:
Yes
EU Entity Country:
Germany
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Fsca Recall Support:
Yes
Additional eu_ar Details
Supports MDR
true
Supports IVDR
true
EU Entity Country
Germany
Post Market Support
Yes
Vigilance Contact Support
Yes
Onboarding Steps
Consent to the processing of personal data as described in the privacy policy is required.
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