What 2C does

2C A/S is a Danish engineering consultancy founded in 1999 and headquartered in Lyngby (Kongens Lyngby), Denmark, providing product development services to MedTech and high-technology companies. The firm specializes in bringing new medical devices to market, with deep expertise in regulatory compliance under ISO 13485, FDA QMSR (21 CFR 820), EU MDR, IVDR, and ISO 14971 risk management, and supports the full development lifecycle from concept and user-needs definition through prototyping, testing, and Design History File (DHF) documentation. Its engineering capabilities span mechanics, optics, usability, measurement technology, flow, pumps, thermodynamics, and controls, with particular strength in design-for-manufacturing (DFM) and design-for-assembly (DfA) for injection moulded components. The company maintains a 250 sqm Innovation Lab equipped with lathes, cutting/bending machines, microscopes, and a LAF bench for prototyping, experimentation, and small-scale production, and draws on a partner network including the Technical University of Denmark, Risø National Laboratories, the University of Copenhagen, and the Danish Technological Institute.

The company's service portfolio comprises Engineering Design Services, QA/RA/QMS consulting, structured medical device development, audit services, and a proprietary MS365-based electronic Quality Management System (eQMS) developed for CSF-Dynamics A/S and certified by DEKRA. Since founding, 2C has been involved in over 700 R&D projects and has supported enterprise clients including Novo Nordisk, Ambu, Coloplast, FOSS, and Radiometer, as well as startups such as MotilityCount ApS (SwimCount), CSF-Dynamics A/S (SinuShunt hydrocephalus implant, first-in-human trial success), Bridge4People, Cleantech Motors, and Nerve Smart Systems. The firm's leadership includes co-authors of three patents for Novo Nordisk medical devices and the credited inventor of the Novo Nordisk FlexTouch disposable insulin injection device (an estimated 3 billion units sold). 2C is a partial owner of two startups — CSF-Dynamics A/S and Graspian A/S — and operates with approximately 20 full-time employees plus a deployed network of external experts.

2C generates revenue through professional services on a project-based, custom-quoted model, with multi-year contract cadence and pricing that is not publicly disclosed; initial consultations are free. Consultants are deployed either on-site with clients in the Greater Copenhagen area or from the firm's Lyngby offices, with account management handled by a dedicated account manager. The go-to-market is sales-led, enterprise field sales anchored by long-term relationships with Denmark's flagship MedTech and life sciences companies, supplemented by conference presence (technology fairs), LinkedIn activity, and a content-driven corporate website. Customer segments are primarily MedTech/medical device companies and broader high-tech product developers, with both large enterprise accounts and early-stage startups. Revenue is not publicly disclosed.

Name

2C

Legal name

2C A/S

Website

https://2c.dk

Company type

Private

Founded year

1999

Operating status

Operating

Headcount range

11–50 employees

Short description

2C A/S is a Danish engineering consultancy providing MedTech device development, regulatory affairs, and QMS services to companies in Greater Copenhagen. Founded in 1999, the firm employs approximately 20 engineers and has completed 700+ R&D projects for clients including Novo Nordisk, Ambu, Coloplast, FOSS, and Radiometer.

Ownership category

akta.pro rank

Product category

Engineering Consultancy

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171), Testing Laboratories and Services (541380), Other Specialized Design Services (54149)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)

akta.pro primary industry

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

akta.pro secondary industry

Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)

Keywords

• Engineering consultancy services
• Medical device development
• Product design services
• Quality management consulting
• Regulatory affairs consulting

Headquarters

HQ city

Lyngby

HQ country

Denmark

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Engineering Consultancy Services: Consulting services for product development, QA/RA/QMS, systems engineering. Consultants work on client projects either in-house at client locations or at 2C offices. Projects range from short-term contracts to complete engineering solutions.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

2C A/S is a Danish engineering consultancy that delivers full-spectrum product development services for high-tech products and MedTech devices, including concept development, detailed design, prototyping, testing, and documentation. Core services span engineering design (mechanics, optics, usability, measurement technology, flow, pumps, thermodynamics, controls), structured medical device development aligned with FDA/EU MDR/ISO 13485, and QA/RA/QMS consulting (ISO 13485, ISO 9001, ISO 14001, ISO 45001 audits, gap analysis, eQMS implementation). An in-house Innovation Lab supports prototyping, experimentation, and small-scale production.

Product overview

2C is an engineering consultancy offering a unified portfolio of product development services for MedTech and high-tech products. The core offering consists of Engineering Design Services (mechanics, optics, usability, measurement technology, flow, pumps, thermodynamics) and QA/RA/QMS Services (quality management, regulatory affairs, audit support). These are complemented by an Innovation Lab facility for prototyping and testing, and a proprietary MS365-based eQMS solution developed for medical device clients. The company uses a structured development process that takes products from concept to market, documented through Design History Files, and supports both ISO 13485 and FDA compliance pathways.

Differentiator

Problem solved

Functional benefit

Products and services

• Engineering Design Services
• QA/RA/QMS Services Quality Assurance, Regulatory Affairs, and Quality Management System consulting covering ISO 13485, FDA QMSR (21 CFR 820), MDR, IVDR compliance, gap analysis, process design, documentation, and audit preparation. For medical device, IVD, and SaMD companies.
• Medical Device Development Structured, step-by-step development process taking medical device products from concept to market, including user needs definition, planning, prototyping, testing, risk management (ISO 14971), and compliance with FDA, EU MDR, and ISO 13485. All stages documented in Design History File (DHF). For MedTech companies developing Class III implants, IVD, and SaMD products.
• Audit Services Internal audits, technical file audits, supplier audits, and product audits for ISO 13485, FDA QMSR, and EU MDR/IVDR requirements, including support during notified body certification and surveillance audits. For medical device, IVD, and SaMD companies.
• MS365-based eQMS Solution Customizable electronic Quality Management System built on Microsoft 365 using familiar tools such as Word and Excel. Designed to meet ISO 13485 standards without subscription fees of traditional eQMS platforms. Developed for CSF-Dynamics A/S and certified by DEKRA. For medical device startups and small/medium companies needing cost-efficient, audit-ready QMS.

Quantifiable outcome

• 500+ product development projects completed in 25+ years
• +4 more outcomes

Named customers10 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Six partnerships are on record, tiered core and minor.

• CSF-Dynamics A/ScoreStrategic or Co-development Partner2C is a partial owner of CSF-Dynamics A/S, a company bringing a revolutionary hydrocephalus shunt to market (a class III medical device). 2C developed the MS365-based eQMS for CSF-Dynamics which was certified by DEKRA. 2C worked on SinuShunt, an innovative implantable shunt system for treatment of hydrocephalus that has been successfully tested in first-in-human clinical trial.
• Graspian A/ScoreStrategic or Co-development Partner2C is a partial owner of Graspian A/S, a company developing tactile sensors for robotic use expanding future robotic applications.
• Technical University of Denmark (DTU)minorOthersPart of 2C's network of external experts that can be drawn upon for specific technology fields when needed for projects.
• Risø National LaboratoriesminorOthersPart of 2C's network of external experts that can be drawn upon for specific technology fields when needed for projects.
• University of CopenhagenminorOthersPart of 2C's network of external experts that can be drawn upon for specific technology fields when needed for projects.
• Danish Technological InstituteminorOthersPart of 2C's network of external experts that can be drawn upon for specific technology fields when needed for projects.

Scale indicators5 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• StarFish Medical: Canadian MedTech-focused product development consultancy providing engineering design, prototyping, and regulatory support for medical device companies. Highly comparable to 2C in vertical specialization, service mix (mechanical design + QMS/RA), and target customer profile of MedTech startups and scale-ups.
• Cambridge Consultants: UK-based product development and engineering consultancy with deep MedTech and high-tech physical product expertise, including prototyping, systems engineering, and regulatory pathway support. Comparable to 2C in full-spectrum product development services for regulated industries.
• NAMSA: Global MedTech-focused contract research organization offering regulatory, quality, testing, and product development consulting for medical device and IVD companies. Overlaps with 2C's QA/RA/QMS offering and MedTech development process expertise, but at much larger scale.
• RQM+: International regulatory and quality consulting firm specializing in MedTech RA/QA, clinical trial support, and product development services. Comparable to 2C's QA/RA/QMS practice and ISO 13485 / EU MDR focus, but operates across global markets.
• Prevas: Swedish engineering consultancy offering product development, embedded systems, and regulatory affairs services to MedTech and industrial customers. Comparable to 2C in Nordic focus, multi-disciplinary engineering scope, and MedTech vertical expertise.

Broad incumbents

• Elos Medtech: Nordic-based contract development and manufacturing organization (CDMO) for medical devices, offering product development, prototyping, and manufacturing. More vertically integrated than 2C into manufacturing, but comparable in MedTech product development focus and Scandinavian footprint.
• NNE: Danish-headquartered engineering consultancy (part of Novo Nordisk) specializing in pharma and biotech process and facility design. Comparable to 2C in Nordic MedTech/life sciences engineering focus and Danish heritage, though focused on pharma capital projects rather than medical device product development.

Emerging players

• FORCE Technology: Danish technology consultancy providing testing, calibration, and product development services across energy, transport, and industrial sectors. Partial overlap with 2C's Innovation Lab and testing/verification capabilities, but broader and less MedTech-focused.

Others

• Danish Technological Institute: Danish applied research institute offering testing, certification, and product development services across multiple industries. Already a partner network member for 2C; comparable in providing specialized technical services to Danish industry, with some overlap in MedTech testing and QA.

Regional players

• PDC (Product Development Company): US-based product development consultancy offering engineering design, prototyping, and manufacturing services for MedTech and consumer products. Comparable in full-service product development scope but serves North American clients rather than Danish/European MedTechs.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks4 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/2c-as/?viewAsMember=true

Compliance9 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 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 2C