Ganymede Consulting

What Ganymede Consulting does

Ganymede Consulting GmbH is a Swiss boutique medical device regulatory consultancy headquartered in Hünenberg, founded in 2009 by David Clerk, an aerospace-trained systems engineer with prior roles at Airbus (A380/A350/A400M programs) and Marshall Aerospace. The firm provides expert advisory services covering regulatory strategy (EU MDR, IVDR, FDA 510(k) and De Novo pathways), ISO 13485 quality management system development, technical documentation, ISO 14971 risk management, IEC 62366 usability engineering, IEC 60601/61010 device safety certification, regulatory submissions, post-market surveillance, and audit preparation. Its primary customer segment is innovative medical device manufacturers seeking global market access, with a secondary audience of industry newcomers addressed through training.

The firm's product portfolio comprises core consulting engagements, a suite of professional training programs (3-day all-inclusive Industry Retreat, Design Controls course, ISO 11608 workshop, custom training), and the proprietary Reg-Int regulatory intelligence platform offering real-time updates on regulatory pathways, device classifications, recognized standards, and a design input generator. Reg-Int is currently bundled with retreat enrollment; merchandise (FDA 510(K) Mug, Mark of the Beast Mug at CHF 19) is sold via a Stripe-backed e-commerce storefront shipping to Switzerland, EU, UK, and US. The senior team includes founder David Clerk, ISO 13485 Lead Auditor Keith (also inaugural ISO/IEC 42001 Lead Auditor), electronics engineer Andrew, and two additional senior consultants pending announcement.

Ganymede operates as a sales-led, direct-engagement professional services firm with a vertical (medical device industry) go-to-market approach. Pricing is predominantly quote-based for consulting and custom training; the firm is bootstrapped and privately held by the founder, with no disclosed external funding, no subsidiaries, and no M&A activity. Industry association memberships (Swiss Medtech, SNV, INCOSE) and founder participation in ISO/TC 84 standards committees support credibility and regulatory intelligence. Revenue, customer concentration, and unit economics are not publicly disclosed.

Name

Ganymede Consulting

Legal name

Ganymede Consulting GmbH

Website

https://gany.ch

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

1–10 employees

Short description

Ganymede Consulting is a Swiss boutique consultancy that helps medical device manufacturers navigate global regulatory pathways (EU MDR/IVDR, FDA), ISO 13485 QMS development, risk management, and technical documentation, complemented by training programs and the Reg-Int regulatory intelligence platform.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Management Consulting Services (54161)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Risk, Compliance & Internal Controls Consulting (BPAHACAJ)

Keywords

• Medical device consulting
• Regulatory compliance services
• Quality management systems
• Risk management consulting
• Regulatory submissions

Headquarters

HQ city

Hünenberg

HQ country

Switzerland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory Consulting Services: Professional consulting engagements providing regulatory strategy, quality management systems, technical documentation, and compliance support for medical device companies seeking global market access.
2. Training Programs: Professional training courses including immersive 3-day retreats, Design Controls courses, ISO 11608 workshops, and custom training programs tailored to specific regulatory needs. Revenue generated through course fees.
3. Merchandise Sales: Sale of branded merchandise including regulatory-themed mugs (FDA 510(K) Mug, Mark of the Beast Mug) priced at CHF 19 each, shipped to Switzerland, EU, UK & US.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

Ganymede Consulting is a specialized consultancy that helps medical device companies navigate regulatory requirements across global markets. Its core offerings include regulatory strategy consulting, ISO 13485 quality management system development, technical documentation, risk management (ISO 14971), usability engineering (IEC 62366), device safety certification (IEC 60601/61010), regulatory submissions (510(k), De Novo, MDR, IVDR), post-market surveillance, and audit preparation. The firm also delivers professional training programs and operates the proprietary Reg-Int regulatory intelligence platform.

Product overview

Ganymede Consulting is a specialized consultancy providing expert guidance on medical device regulations, quality systems, and global market access strategies. Their offering is a portfolio of consulting services organized around core regulatory expertise: Regulatory Strategy Consulting (covering EU MDR, IVDR, FDA pathways including 510(k) and De Novo), Quality Management System Development (ISO 13485), Technical Documentation, Device Safety Certification (IEC 60601/61010), Risk Management (ISO 14971), Usability Engineering (IEC 62366), Regulatory Submissions, Post-Market Surveillance, and Audit Preparation. They also operate the Reg-Int platform as their proprietary regulatory intelligence tool for monitoring global regulatory changes and device portfolio impact. Their training arm includes the 3-day Medical Device Industry Retreat, ISO 11608 Training, Design Controls Training, and Custom Training Programs. The firm was founded by David Clerk and offers end-to-end regulatory and quality solutions to help medical devices reach global markets.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Strategy Consulting

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Two partnerships are on record, tiered minor and core.

• Partner PhysiciansminorStrategic or Co-development PartnerCollaborates with partner physicians for the development of clinical harms lists, bringing medical expertise to regulatory compliance assessments for medical devices.
• Reg-Int PlatformcoreTechnology or IntegrationThe Reg-Int platform is Ganymede's proprietary regulatory intelligence tool providing real-time updates on major jurisdiction regulatory pathways, device classifications, recognized standards, and design input generator. Offered as part of training retreat package with 3 months free access for participants.

Scale indicators3 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• Cognition Corporation: Cognition Corporation is a medical device-focused regulatory and quality consulting firm offering ISO 13485, FDA, and EU MDR support — directly overlapping with Ganymede's core service lines for medtech manufacturers.
• Emergo by UL: Emergo by UL is the medical device regulatory consulting arm of UL, covering EU MDR/IVDR, FDA, and global market access. It directly competes with Ganymede on the same regulatory pathway, QMS, and technical documentation engagements.
• Medidee Services: Medidee is a Switzerland-based medical device regulatory, quality, and clinical consulting firm — the closest geographic and service-overlap peer to Ganymede, also serving EU MDR/IVDR clients with similar boutique positioning.
• I3CGLOBAL: I3CGLOBAL is an international regulatory and quality consulting firm specializing in medical devices, IVDs, and combination products. It overlaps with Ganymede on EU MDR/IVDR and FDA submission work for innovative medtech.
• RQM+: RQM+ (formerly R&Q Solutions) is a medical device regulatory and quality consulting firm specializing in ISO 13485, FDA, EU MDR/IVDR submissions — a near-exact overlap with Ganymede's service portfolio, but with a much larger US-based consulting bench and acquired service lines.
• NAMSA: NAMSA is the largest pure-play medical device-focused regulatory, quality, and testing CRO globally. It competes directly with Ganymede for medical device QMS, safety testing, and regulatory submission work, but at significantly larger scale and with in-house labs.
• Veranex: Veranex is a medical device-focused CRO combining regulatory, clinical, design, and engineering services. It competes with Ganymede on the regulatory and quality side of medtech programs, with broader end-to-end coverage.

Broad incumbents

• Greenlight Guru: Greenlight Guru is a medical device QMS and regulatory workflow SaaS platform. While not a services firm, it competes for the same ISO 13485 QMS, design controls, and regulatory submission budgets that Ganymede sells consulting hours against.
• MasterControl: MasterControl provides enterprise QMS, document, and compliance software used across life sciences including medical devices. It is a broader-incumbent competitor for QMS-related consulting engagements where Ganymede helps implement ISO 13485 systems.
• Parexel: Parexel is a large global CRO with regulatory affairs capabilities spanning pharma and medical devices. It is a broader incumbent that competes for the largest medical device regulatory programs but is less specialized than Ganymede in pure medtech.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/ganymede-consulting-gmbh

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 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 Ganymede Consulting