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 comprehensive suite of services beyond just the EU Authorized Representative role. Their offerings extend to critical areas such as Risk Management & Usability, Clinical Evaluation, and Software Validation, ensuring a holistic approach to medical device compliance. They also support QMS adaptation and interim management needs, demonstrating flexibility in addressing diverse client requirements. For product development, they offer expertise in Mobile Apps and App Development, covering both internal and external projects.
Key Highlights
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Specializes in EU Authorized Representative services for medical devices.
Source
“VISAMED is a specialized consulting company providing regulatory affairs and quality management services for medical devices. They offer expertise in EU Authorized Representative services”
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Offers a range of regulatory affairs and quality management services.
Source
“EU Authorized Representative Service Risk Management & Usability Clinical Evaluation Software Validation QMS”
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Based in Karlsruhe, Germany.
Source
“Kastellstraße 8 D‑76227 Karlsruhe, Germany”
Certifications & Trust Signals
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Registered in the Commercial Register at Amtsgericht Mannheim, HRB 733623.
Source
“Commercial Register: Amtsgericht Mannheim, HRB 733623”
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Holds a German 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 regulatory affairs in the EU.
- Businesses requiring assistance with Quality Management Systems (QMS) and software validation.
How engagement typically works
- Consulting-based engagement for regulatory affairs.
- Project-specific support for product approval and validation.
- Ongoing support for QMS and post-market activities.
Typical deliverables
- Designation as EU Authorized Representative.
- Regulatory strategy and submission support.
- QMS documentation and implementation.
- Software validation reports.
- Risk management files.
Good to know
- Best when clients require specialized regulatory and quality management expertise for medical devices within the EU.
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
Device Classes Supported
Not explicitly stated
Supports MDR
Implied by EU Authorized Representative services
Supports IVDR
Implied by EU Authorized Representative services
EU Entity Country
Germany
Fsca Recall Support
Not explicitly stated
Post Market Support
Implied by QMS and regulatory affairs services
Vigilance Contact Support
Implied by EU Authorized Representative services
Onboarding Steps
Not explicitly stated
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