Visamed

What Visamed does

VISAMED GmbH is a privately held, specialized consulting firm headquartered in Karlsruhe, Germany, with an additional professional team presence in Barcelona, Spain. Founded in 2002, the firm provides a full range of regulatory affairs, quality management, clinical evaluation, and product development services to medical device and in vitro diagnostics companies worldwide. Its service portfolio covers EU MDR (2017/745) and IVDR (EU 2017/746) compliance, FDA pathways (510(k), PMA, IDE), Health Canada licensing, ISO 13485 and 21 CFR §820 quality system setup, IEC 62304 software lifecycle compliance, IEC 62366 usability engineering, ISO 14971 risk management, and European Authorized Representative (EC REP) services for non-EU manufacturers.

The firm's technical capabilities extend beyond pure advisory work into hands-on product development, particularly for software-as-a-medical-device. VISAMED delivers complete medical mobile application development for iOS and Android, including backend infrastructure (Java/Tomcat, Python), signal processing for audio and imaging applications, IEC 62304-compliant development processes, app store submission, and CE marking. The most prominent external demonstration of this capability is the co-development with Jacoti bvba of ListenApp, described as the world's first software hearing aid for the iPhone to achieve CE approval as a Mobile Medical Device. The firm also participates in the InnoDiss R&D project with Charité Berlin, supported by BMBF grant 13GW0720, developing a stentgraft for minimally invasive treatment of Acute Aortic Dissection Type A.

The business model is professional services, with revenue generated from project-based regulatory consulting engagements, QMS setup and training, medical mobile app development, interim management placements, and recurring EC REP retainer relationships. Pricing is not publicly disclosed; all inquiries route through the company's website contact form, direct email, or phone. Customer acquisition is relationship-driven and field-sales oriented, consistent with long-cycle B2B regulatory engagements. The firm operates with 1-10 employees, serves "dozens of medical companies" across multiple therapeutic areas (cardiovascular, neurology, orthopedics, ophthalmology, oncology, gastroenterology, ENT, diabetes), and is led by Managing Director and CEO Arne Briest. The company is privately held with no disclosed funding rounds, investors, or M&A activity.

Name

Visamed

Legal name

VISAMED GmbH

Website

https://visamed.com

Company type

Private

Founded year

2002

Operating status

Operating

Headcount range

1–10 employees

Short description

VISAMED is a privately held German consulting firm that provides regulatory affairs, quality management, clinical evaluation, and medical mobile app development services to medical device and IVD companies seeking market clearance in Europe, the USA, and Canada.

Ownership category

akta.pro rank

Headquarters

HQ city

Karlsruhe

HQ country

Germany

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Regulatory Affairs Consulting: VISAMED provides regulatory strategy and submission support for medical device companies seeking market clearance in Europe (CE marking/MDR), Canada (medical device license), and the USA (510(k), PMA, IDE submissions). These are project-based consulting engagements.
2. Quality Management Systems Consulting and Training: QMS setup, adaptation, and training services for medical device companies. Includes ISO 13485 implementation, internal audits, CAPA system development, and FDA QSR (21 CFR §820) compliance support. Both consulting engagements and training services.
3. Medical Mobile App Development: Complete development of Medical Mobile Apps including regulatory approval, backend server setup, and app store submission. This is a full-service product development engagement for medical mobile applications.
4. Interim Management: Provides interim management resources and skills to medical device companies during periods of transition, crisis, or change. Includes leading development teams and assuring regulatory compliance worldwide. This is a contracted management services engagement.
5. European Authorized Representative Services: Acts as EC REP for non-EU medical device manufacturers, providing regulatory liaison with European competent authorities, EUDAMED registration, incident reporting, and secure document access for clients. Ongoing retainer-style services as long as devices are sold in Europe.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

Visamed is a specialized consulting firm providing a full range of regulatory affairs, quality management, and product development services to medical device and in vitro diagnostics companies worldwide. The firm supports clients across Europe (CE marking/EU MDR), Canada (Medical Device License), and the USA (510(k), PMA, IDE submissions), and additionally serves as European Authorized Representative (EC REP) for non-EU manufacturers seeking market access to Europe.

Product overview

VISAMED is a consulting company offering a comprehensive suite of services for medical device and in vitro diagnostics companies worldwide. The portfolio includes Regulatory Affairs (Europe, Canada, USA market clearance), Quality Management Systems (QMS), EU Authorized Representative services, Clinical Evaluation, Software Validation, Risk Management & Usability, and Mobile Apps development. Services are delivered through dedicated modules that work together to support medical device companies from development through regulatory approval and market surveillance. VISAMED also conducts research through the InnoDiss project for aortic dissection treatment.

Differentiator

Problem solved

Functional benefit

Brands

• InnoDiss: A stentgraft development project for minimal-invasive treatment of Acute Aortic Dissection Type A (ATAAD), developed in partnership with Charité and supported by BMBF grant 13GW0720.

Products and services

• Regulatory Affairs Development of effective regulatory strategy and market clearance support for medical device companies seeking approval in Europe (CE marking/EU MDR), Canada (Medical Device License), and the USA (510(k), PMA, IDE submissions). Includes technical file preparation, notified body coordination, labeling, translation of technical documentation, and post-market surveillance compliance.
• EU Authorized Representative (EC REP) Acts as European Authorized Representative (EC REP) for medical device manufacturers under EU MDR (2017/745) and IVDR (EU 2017/746). Services include evaluating Technical Files, registering medical devices/IVDs in EUDAMED, maintaining EUDAMED database entries, assisting with incidents and adverse events, Field Safety Corrective Action (FSCA), and providing secure online access to all documentation and regulatory data.
• Quality Management Systems (QMS) Setup and adaptation of quality management systems to comply with regulatory requirements for Europe (ISO 13485) and USA (21 CFR §820). Includes QMS implementation, internal audits, CAPA system development, FDA QSR compliance support, and supplier assessments.
• Clinical Evaluation Planning, designing, and executing clinical evaluations and clinical studies compliant with EU MDR (2017/745). Includes Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) preparation, comprehensive analysis of pre- and post-market clinical data, clinical performance and safety data review, and alignment with MEDDEV 2.7.1, MDCG guidance documents, and IMDRF standards.
• Software Validation Medical device software development support including software verification, validation, translation, and localization services per IEC 62304 (medical software lifecycle) and IEC 62366 (usability engineering). Includes continuous integration and automatic software testing, static code analysis, specifications/requirements for software tests, and software validation planning/execution with users.
• Risk Management & Usability Risk management per ISO 14971 and human-computer interaction/usability engineering per IEC 62366 for medical devices. Includes interface planning, prototype testing, graphical user interface analysis, and specialized design of software and mobile apps for kids, elderly patients, and individuals with disabilities, aligned with FDA guidance on human factors.
• Medical Mobile App Development Complete development of Medical Mobile Apps from concept to regulatory approval on iOS and Android, including backend server setup (Java/Tomcat, Python) and IEC 62304 compliance. Includes experience with iOS and Android APIs, location-triggers, QR codes, privacy/security, Facebook integration, multimedia streaming, signal processing for audio and imaging applications, and app store submission support.
• Interim Management Provides interim management resources and skills to medical device companies during periods of transition, crisis, or change. Includes leading development teams and assuring regulatory compliance worldwide, with experience serving both European and USA-based medical device companies.

Named customers1 record

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Two partnerships are on record, tiered core and major.

• Charité (Berlin)coreStrategic or Co-development PartnerVISAMED is collaborating with Charité Berlin on the InnoDiss project, which received BMBF grant support (Grant 13GW0720) to develop a Stentgraft for minimally invasive treatment of Acute Aortic Dissection Type A (ATAAD). The project aims to bring a paradigm shift similar to TAVI to the treatment of this rare, life-threatening cardiovascular emergency. VISAMED contributes regulatory expertise and product development capabilities to this co-development effort with Charité's cardiovascular medicine team.
• Jacoti bvbamajorStrategic or Co-development PartnerVISAMED helped Jacoti bvba develop ListenApp, described as the world's first software hearing aid for the iPhone that is a CE-approved Mobile Medical Device. VISAMED provided complete product development services including design, development, and regulatory approval (CE marking). This is a product co-development partnership resulting in a CE-certified mobile medical device available on the iOS App Store.

Scale indicators1 record

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• NAMSA: Larger medical device-focused CRO and regulatory consulting firm offering testing, clinical, and regulatory services globally. Competes with Visamed on regulatory and clinical evaluation engagements but at materially greater scale.
• DEKRA: International Notified Body and TIC firm offering medical device certification, testing, and regulatory consulting across EU, US, and Asia. Competes with Visamed for regulatory and certification engagements, particularly for manufacturers seeking combined testing + consulting.
• ICON plc: Global CRO and consulting services provider with a medical device regulatory practice. Competes for larger, integrated regulatory-clinical engagements Visamed would partner on or sub-contract for.
• Bureau Veritas (incl. BSI): Global TIC firm with medical device Notified Body and consulting services. After acquiring BSI's Medical Devices business, it competes in MDR/IVDR certification and adjacent regulatory consulting.
• TÜV SÜD: Global Notified Body and testing/consulting conglomerate that also provides regulatory and quality consulting for medical device manufacturers. Larger scale and notified body status create both competition and partnership dynamics with Visamed.
• Parexel International: Large global CRO offering regulatory affairs, clinical, and consulting services to medical device and pharma clients. Competes with Visamed for larger, multi-jurisdiction regulatory engagements where scale matters.

Emerging players

• Akeso GmbH: Specialized medical device regulatory and quality management consultancy focused on EU MDR compliance, ISO 13485, and software-as-a-medical-device. A small, niche competitor comparable in size and target customer base to Visamed.

Direct peers

• Qserve Group: Europe-based medical device regulatory and quality consulting firm with deep MDR/IVDR expertise, EC REP, clinical evaluation, and notified body support — closely comparable in size, geography, and service mix.
• RQM+: Medical device regulatory and quality consulting firm providing MDR/IVDR transition, clinical evaluation, and remediation services. Similar mid-sized consultancy profile competing for the same European medtech client base.
• Emergo by UL (UL Solutions): Global medical device and IVD regulatory affairs consultancy offering CE marking, EC REP, FDA, Health Canada, and quality system services. Closest direct competitor to Visamed in scope, with broader geographic footprint.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInde.linkedin.com/pub/arne-briest/5/621/8a2

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Visamed