MedtechGuide_2027_Flyer

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2027

Guide to German

Medtech Companies

4-79-383829-3-879 NBSI

Name › HEITEC AG Address/P.O. Box › Gueterbahnhofstrasse 5 Postal Code/City › 91052 Erlangen State › Bavaria Contact Person › Horst Dietz Telephone › +49-9131-877-0 Email › info@heitec.de Website › www.heitec.de Social Media › I Q  I Number of Employees › 1,200 in the HEITEC Group Founded (year) › 1984 Areas of Activity › Special machinery, electronics (design, production and enclosure systems), cybersecurity, software and hardware, test Annual Turnover › €166m in 2024

HEITEC offers high-quality, integrated and innovative solutions, products and services in automation, digitalisation, electronics, energy technology, software engineering and special machinery.

With cost-effective, end-to-end solutions and years of industry expertise, HEITEC supports over 2,000 customers to increase their productivity and optimise their products. With more than 1,200 employees at numerous locations in Germany and abroad, HEITEC guarantees customer proximity and industry expertise.

HEITEC – your partner for innovative medical solutions Development, manufacturing and service expertise from a single source HEITEC is a trusted leader in electronics, automation, digitalisation and special machine construction, delivering medical technology solutions that unite innovation with uncompromising quality and safety. Its Electronics Engineering and Manufacturing Services (E 2MS²) cover hardware and software development, production and housing technology – all from one source. With a global footprint and proven expertise in certification processes, HEITEC enables customers to bring safe, reliable medical devices to market faster. Compliance with ISO 27001, ISO 13485, EN 60601-1, EN 62304 and GMP guidelines is standard. From defining system architecture and developing components to fully integrated systems, HEITEC offers end-to-end expertise including verification, validation, in-house review processes and documentation. Long-term product support, procurement management and aftermarket services ensure cost-efficient, sustainable and future-proof solutions across the entire lifecycle.

Customer success stories prove significant value Member of

Fully integrated systems for groundbreaking neurostimulation therapy An innovative regional company specialising in transcranial magnetic stimulators (TMS) partnered with HEITEC

HEITEC

© neurocare, HEITEC, Leipold

to grow into a global player. HEITEC provided complete system integration tailored to specifications – from board assembly and housing integration to functionality testing and delivery of operational systems with multilingual manuals. The customer benefits from seamless procurement, long-term supply chain management and reproducible production processes with strict quality control adapted to international needs. Thanks to scalable production in Germany, the company can respond swiftly to fluctuating demand, volatile procurement conditions, regulatory changes or redesigns.

Modular handling machine for pharmaceutical vials

© Future Production sh.p.k, HEITEC

© Future Production sh.p.k, HEITEC

© iStock-1313834139 - Dilok Klaisataporn

For a leading global pharmaceutical company, HEITEC developed and implemented a GMP-compliant handling system for medical vials. Integrated into an ISO 146441 Class 9 cleanroom, the solution meets the highest standards of safety and efficiency. Its compact, modular design enables flexible handling of different vial sizes.

A key element was the use of a digital twin, allowing extensive testing of robotics and control systems prior to installation. The simulation accelerated realisation, reduced risks and ensures smooth adaptation to future demands. Today, the system operates reliably around the clock, with modular architecture and digital twin support guaranteeing long-term value and resilience in production.

Cybersecurity is mandatory HEITEC embeds cybersecurity into every solution, ensuring compliance with NIS2, CRA, MDR and FDA regulations. With a secure-by-design approach, advanced threat modelling (STRIDE, EMB3D, PASTA, DREAD) and continuous updates, HEITEC safeguards infrastructures against manipulation, supply chain attacks and unauthorised access. Measures include encrypted protocols, firewalls, malware scanning and role-based access. Secure firmware design prevents tampering and strengthens resilience, while systematic risk analysis and lifecycle testing guarantee reliability.

Customers benefit from future-proof systems backed

by HEITEC’s expertise and commitment to regulatory excellence, including adherence to IEC 81001-5-1, IEC 62304 and ISO 14971.

GUIDE TO GERMAN MEDTECH COMPANIES 2026

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Rückantwort (Rückfragen unter 030-264921-49) Knowbio GmbH Jacobsenweg 61 13509 Berlin

b.io E-Mail: boehm@know n. christia

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Guide to German Medtech 2027