Medtech Ingenieur Gmbh

What Medtech Ingenieur Gmbh does

MEDtech Ingenieur GmbH is a German medical device engineering services company founded in 2007 and headquartered in Erlangen within the Medical Valley cluster. The firm provides end-to-end development, testing, and ISO 13485-certified contract manufacturing for medical device manufacturers, startups, and SMEs requiring CE-compliant, regulatory-ready products. The service portfolio covers embedded software development (including Zephyr RTOS, FPGA programming, and IEC 62304 lifecycle compliance), hardware development with sensor and circuit design per IEC 60601 and EMC standards, a dedicated TestLab for functional, EMC, climate, and integration testing, and small-to-medium batch production under a TÜV-certified quality system.

The company also offers proprietary technology modules — EDA sensors, motion sensors for gait analysis, CPR feedback sensors, and electrical stimulation — and a differentiated BLE synchronization protocol (bsync module) achieving 50-microsecond precision for distributed wireless medical sensors. Its integrated 'Production Hub' concept bridges prototype development and series production within a single ISO 13485-compliant quality system, reducing provider-switching friction during design transfer. Other notable capabilities include VectorCAST-based unit and integration testing for safety-critical software with MC/DC coverage, IEC 62304 gap analysis for FPGA software classification, and supply-chain-resilient regional manufacturing.

The business model is B2B project-based professional services with a hardware sales component from contract manufacturing, operating on a quote-based engagement model through direct sales and website inquiry forms. Target segments are established medical device manufacturers, MedTech startups entering regulated manufacturing for the first time, and MedTech SMEs without internal production infrastructure. Operating geographies are concentrated in the DACH region. The company is privately held by its two managing directors, Goran Madzar and Martin Bosch, with no disclosed external funding or parent company.

Name

Medtech Ingenieur Gmbh

Legal name

MEDtech Ingenieur GmbH

Website

https://medtech-ingenieur.de

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

11–50 employees

Short description

MEDtech Ingenieur GmbH is a German medical device engineering services firm providing embedded software, hardware development, testing, and ISO 13485-certified contract manufacturing for medical device manufacturers, startups, and SMEs in the DACH region.

Ownership category

akta.pro rank

Headquarters

HQ city

Erlangen

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Engineering Services: Full-service engineering support for medical device development including software development, hardware development, prototyping, and regulatory compliance services. Revenue generated through project-based consulting engagements and development contracts.
2. Testing & Validation Services: MEDtech TestLab services providing function tests, standard tests, EMC tests, climate tests, and integration tests for medical devices. Charged per test or project basis.
3. Production & Manufacturing: ISO 13485 compliant manufacturing including prototyping, small batch production, and scalable series manufacturing for medical devices.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

MEDtech Ingenieur GmbH is an Erlangen-based engineering service provider that develops embedded software and hardware for medical devices. The company offers end-to-end development services including product design, embedded firmware, testing, regulatory gap analysis (IEC 62304), and small-series manufacturing for medical technology clients.

Product overview

MEDtech Ingenieur GmbH is a medical technology engineering services company offering a comprehensive portfolio of development, testing, and manufacturing services for medical devices. The company operates as a one-stop solution provider with integrated service offerings including Software Development (with embedded software, Zephyr RTOS, and IEC 62304 compliance), Hardware Development, MEDtech TestLab (functional, EMC, climate, and integration testing), Production & Manufacturing (ISO 13485 compliant small-batch and series production), and IEC 62304 Gap Analysis. Their technology module offerings include EDA Sensors, Motion Sensors for Gait Analysis (with BLE synchronization precision down to 50µs), CPR Feedback Sensors, and Electrical Stimulation modules. The company also offers a Production Hub concept that integrates development, regulatory compliance, and manufacturing under one system for seamless design transfer from prototyping to series production.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Device Software Development Custom embedded software development for medical devices, delivered to medical device OEMs requiring IEC 62304-compliant firmware and application code.
• Medical Device Hardware Development Electronic and mechanical hardware design for medical devices, including sensor integration and electrical stimulation circuitry for OEMs.
• Medical Device Testing Verification and validation testing services for medical device hardware and software, supporting regulatory submissions.
• IEC 62304 Gap Analysis Regulatory gap analysis and remediation services for medical device software development processes per IEC 62304.
• Small-Series Manufacturing Small-batch and pilot-series manufacturing of medical devices and electronic modules for OEM clients.

Named customers4 records

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• Medical ValleycoreStrategic or Co-development PartnerActive member of Medical Valley cluster, a leading European medical technology innovation network based in Erlangen. Provides networking opportunities, industry visibility, and collaborative ecosystem for medical device development companies.

Scale indicators4 records

Recent moves5 records

Expansion highlights4 records

Broad incumbents

• TÜV SÜD: Global testing, inspection, certification, and training giant with deep medical device regulatory expertise (MDR, IVDR, ISO 13485, IEC 60601). Comparable as a medtech certification/testing reference point for European manufacturers, though far broader in scope and scale than MEDtech Ingenieur.
• Phillips-Medisize: Large global medical device CDMO offering design, development, and high-volume contract manufacturing for drug delivery, diagnostics, and connected health. Comparable in offering (medtech CDMO), but operates at significantly larger scale and broader geographic footprint than MEDtech Ingenieur.

Direct peers

• Johner Institut: German medical device regulatory and quality management consultancy offering IEC 62304, MDR, and ISO 13485 support to medtech manufacturers and startups. Highly comparable to MEDtech Ingenieur in target customer (DACH medtech OEMs and startups), regulatory depth, and service-led delivery model.
• NAMSA: Global medical device testing, regulatory, and quality consulting CRO serving medtech manufacturers across functional, EMC, biocompatibility, and sterilization testing. Directly comparable to MEDtech Ingenieur's TestLab services for CE-marked medical devices.
• Medidee Services: Swiss-headquartered medical device regulatory, quality, and clinical consultancy serving European medtech manufacturers. Comparable to MEDtech Ingenieur as a Europe-based, regulation-focused service provider for MDR/IVDR compliance, gap analysis, and CE marking support.
• StarFish Medical: Canadian medical device product development firm providing design, engineering, regulatory, and manufacturing services for medtech OEMs and startups. Comparable in full-lifecycle medtech engineering services spanning embedded hardware/software, testing, and design transfer.
• Qserve Group: Dutch medical device regulatory affairs, quality assurance, and clinical consulting firm with a strong DACH customer base. Closely comparable in services (MDR, IVDR, ISO 13485) and target audience of European medical device manufacturers.
• Elos Medtech: Swedish medical technology contract development and manufacturing organization (CDMO) offering orthopedic, dental, and diagnostics contract manufacturing. Comparable to MEDtech Ingenieur in European medtech contract manufacturing and ISO 13485 production services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/medtech-ingenieur

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 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 Medtech Ingenieur Gmbh