Axxos

What Axxos does

Axxos AG is a privately-held, founder-owned Swiss consulting firm founded in 2008 and headquartered in Rombach, Switzerland. The company provides professional services to the medical device industry across three regulatory regimes — EU MDR, Swiss MedDO/MepV, and US FDA 21CFR820 — covering quality management system implementation and certification (ISO 13485, MDSAP, 21CFR820), regulatory affairs and technical documentation, clinical evaluation and post-market surveillance, risk management (ISO 14971), computer system validation, qualification/validation, gap analyses and internal audits, and inspection-readiness support for Swissmedic, cantonal authorities, and the FDA. The firm also serves healthcare facilities (hospitals, care homes) in establishing compliant QMS for medical device reprocessing and procurement.

The business generates revenue through two primary streams. First, project-based consulting mandates awarded through direct enterprise engagement, with engagement terms confirmed in writing and pricing quoted per project. Second, training and education services, including the only German-language IRCA-certified Lead Auditor ISO 13485 course in Switzerland (CHF 3,300 per participant, delivered twice yearly in the Aarau region), topic-specific public seminars, customized in-house corporate training, and a subscription-style regulatory-update service. The firm operates an online training platform at training.axxos.ch and contributes content to the IMT Academy via an August 2024 strategic partnership.

Axxos employs 13 staff holding 253 years of collective medical-technology experience and serves a diversified mix of customers including multinationals (DePuy Synthes / Johnson & Johnson MedTech, Smith & Nephew, Haag-Streit, Messer Schweiz), mid-market manufacturers (Mathys, Cascination, Wyon), SMBs (Argotec, Fumedica, Gsell Medical Plastics, Laubscher Präzision, Andres AG), startups (Genostis, Okin, ZuriMed), and healthcare facilities (Luzerner Kantonsspital, Universitätsspital Basel). Cross-border service capability is delivered through partner organizations Axxos GmbH (Germany) for EU-REP services, Swiss AR Services AG for CH-REP services, and former FDA inspector Lance D. Johnson for US-Agent services. No software or hardware products are sold; the firm's "technology" is its accumulated regulatory expertise, audit experience (>200 ISO 13485 audits, >20 FDA inspections without warning letters), and certified training credentials (IRCA course certification, EduQua certification since May 2025).

Name

Axxos

Legal name

AXXOS AG

Website

https://axxos.ch

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

11–50 employees

Short description

Axxos AG is a Swiss consulting firm specializing in quality management and regulatory affairs for medical devices, serving manufacturers, suppliers, and healthcare facilities across the EU, Switzerland, and the USA through project-based consulting and certified training.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Management Consulting Services (54161), Management, Scientific, and Technical Consulting Services (5416)

SIC

Services-Management Consulting Services (8742), Services-Engineering, Accounting, Research, Management (8700)

akta.pro primary industry

Inspection Readiness & Regulatory Authority Support (FDA/EMA/MHRA) (HLAGAKAF)

akta.pro secondary industries

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA), Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL), Training & Competency Programs for GxP Compliance (HLAGAKAM), GxP Audits & Supplier Qualification (GMP/GCP/GLP/GDP) (HLAGAKAE)

Keywords

• Medical device consulting
• Quality management systems
• Regulatory affairs
• ISO 13485 compliance
• FDA services

Headquarters

HQ city

Rombach

HQ country

Luxembourg

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Consulting Services: Axxos provides expert consulting engagements in quality management systems (ISO 13485, FDA 21CFR820, MDSAP), regulatory affairs (EU MDR, Swiss MedDO/MepV, FDA 510(k), de novo), risk management, clinical evaluation, post-market surveillance, and validation/qualification. Mandates are assigned on a project basis, with clear contractual terms and termination policies. Consulting is the primary revenue driver.
2. Training and Education Services: Axxos offers public training programs (e.g., the IRCA-certified Lead Auditor course at CHF 3,300 per participant) and in-house/corporate training across all expertise areas. Training events are offered publicly and in private, with registration-based enrollment and EduQua-certified certificates. A dedicated online training platform (training.axxos.ch) also hosts online courses.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels5 records

Core offering

Axxos AG is a Swiss professional services firm delivering expert consulting and training in quality management and regulatory affairs for the medical technology industry. Services span ISO 13485 / MDSAP / FDA 21CFR820 quality system implementation, EU MDR and Swiss MedDO/MepV regulatory strategy, FDA 510(k) and inspection readiness, clinical evaluation, post-market surveillance, risk management, and authorized representative services (EU-REP/CH-REP/US-Agent). The firm also runs the only German-language IRCA-certified Lead Auditor training in Switzerland and an EduQua-certified public and in-house training program.

Product overview

Axxos is a Swiss consulting company offering professional services in quality management and regulatory affairs for the medical technology industry. The company provides a comprehensive portfolio of consulting services rather than software products, including Quality Management Services (ISO 13485, MDSAP, FDA 21CFR820), Regulatory Affairs (technical documentation, CE marking, 510(k) submissions), EU MDR/MedDO compliance, FDA Services (inspections, submissions, US-Agent), Clinical Evaluation, Post-Market Surveillance, Risk Management, and professional training programs including the only IRCA-certified Lead Auditor training in German-speaking Switzerland. The services are structured around key areas: Quality Management Services, Regulatory Affairs, Healthcare Facilities, EU MDR/MedDO, FDA Services, Gap Analysis and Audits, Trainings, and Update Services for Standards and Regulations.

Differentiator

Problem solved

Functional benefit

Products and services

• Quality Management Services (ISO 13485 / MDSAP / FDA 21CFR820)

Quantifiable outcome

• Successfully supported more than 20 FDA inspections without a warning letter
• +2 more outcomes

Named customers28 records

Segments5 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered core.

• IMT AGcoreStrategic or Co-development Partner · 21 August 2024Axxos AG and IMT AG formed a strategic partnership to develop the IMT Academy (launched in 2024), which focuses on continuing education for medical technology professionals in QM, RA, and risk management. Axxos contributes expertise in medical device approval, ISO/FDA QMS implementation, validation support, and authority inspection preparation. The partnership leverages joint synergies to deliver high-quality, practice-oriented courses and expand reach through the IMT Academy platform.
• sitem-insel (Swiss Institute for Translational and Entrepreneurial Medicine)coreStrategic or Co-development PartnerAxxos serves as an Educational Partner to sitem-insel, providing quality management expertise in teaching. Markus and Susanne from Axxos deliver high-quality, interactive lessons highly appreciated by students. Axxos is characterized by a good view of the bigger picture and contributes to the overall curriculum beyond their own teaching content.
• Swiss AR Services AGcoreTechnology or IntegrationAxxos partners with Swiss AR Services AG for CH-REP (Swiss Authorized Representative) services. Since May 26, 2021, products from abroad require a Swiss authorized representative when placed on the Swiss market. Swiss AR Services AG is one of the larger CH-REPs, and Axxos refers clients to them for this service while providing complementary regulatory consulting.
• Axxos GmbH (Germany)coreTechnology or IntegrationAxxos GmbH, based in Germany, serves as the EU Authorized Representative (EU-REP) for Swiss manufacturers placing medical devices on the EU market. Axxos AG (Switzerland) collaborates closely with Axxos GmbH to provide seamless regulatory services across the Switzerland-EU boundary. Swiss medical devices require an EU-REP under EU MDR, and Axxos GmbH fulfills this role.
• Lance D. Johnson (Former FDA Inspector)coreTechnology or IntegrationAxxos cooperates with Lance D. Johnson, a long-time former FDA inspector, to provide US Agent services for foreign manufacturers. A US Agent is required for all foreign manufacturers to legally market medical devices in the US. This partnership enables Axxos to offer comprehensive FDA market entry support, including establishment registration, 510(k) consulting, and FDA inspection preparation.

Scale indicators6 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Qserve Group: Qserve is a Netherlands-based medtech consulting firm specializing in regulatory affairs, quality management, and clinical compliance for medical devices across EU MDR, US FDA, and other global frameworks. It directly mirrors Axxos's boutique consulting model with comparable service lines (ISO 13485, FDA submissions, clinical evaluation) and serves as its most direct European competitor.
• IMA Institut für Management und Assurance: IMA is a German consulting firm focused on quality management, regulatory affairs, and validation services for the medical device and pharmaceutical industries. Its boutique structure and service mix closely match Axxos, making it a direct peer in the DACH MedTech consulting market.
• Johner Institut: Johner Institut is a German-Swiss medtech consulting and training firm providing regulatory affairs, QM, and software compliance services for medical device manufacturers. It directly competes with Axxos in the DACH-region MedTech consulting market, with particularly strong overlap on ISO 13485, MDR technical documentation, and training programs.
• Metecon: Metecon is a Mannheim, Germany-based medtech consulting firm focused on regulatory affairs, quality management, and validation for medical device manufacturers. Its service portfolio (MDR technical documentation, FDA submissions, QM systems, clinical evaluation) directly overlaps with Axxos's offerings for the same European MedTech customer base.
• RQM+: RQM+ is a US-headquartered medtech regulatory and quality consulting firm serving medical device and IVD companies with RA, QA, clinical, and reimbursement services. It is a direct peer given similar scope (FDA submissions, ISO 13485, clinical evaluation, post-market) and operates as a comparable-sized specialist competitor in the global MedTech consulting market.

Broad incumbents

• TÜV SÜD: TÜV SÜD is a global testing, inspection, and certification (TIC) giant offering ISO 13485 certification, medical device testing, and regulatory consulting as part of its broader portfolio. It competes with Axxos on certification audits and larger enterprise QMS engagements, but does not specialize in boutique regulatory consulting for Swiss SMEs.
• NSF International: NSF provides medical device certification, regulatory consulting, and training services globally, including ISO 13485 certification and FDA-related support. It is a broad incumbent peer offering overlapping capabilities but at significantly larger scale and with broader service breadth than Axxos's boutique Swiss practice.
• BSI Group: BSI is a global standards and certification body that issues ISO 13485 certificates and offers medical device regulatory consulting. As an incumbent, it overlaps with Axxos on certification-related consulting but operates at much larger scale and with a broader geographic footprint than the Swiss firm.
• DEKRA: DEKRA is a global TIC incumbent offering medical device certification, regulatory testing, and certification audits. It competes with Axxos for larger enterprise mandates and certification-related work but does not match Axxos's specialized SME-focused, partner-network-enabled model in Switzerland.

Others

• IMT AG: IMT AG is Axxos's strategic partner in developing the IMT Academy for MedTech continuing education. While not a direct competitor (the relationship is mutually cooperative), IMT operates in adjacent medtech training and consulting space and offers a useful benchmark for content-driven MedTech education businesses in the Swiss market.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/axxos-ag

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

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 Axxos