Company

HELLER MEDIZINTECHNIK GmbH & amp; Co. KG has been successful throughout Germany for 25 years. 10 employes are seated at the head quarters in Braunfels, while 4 sales representatives maintain contacts to target groups all over Germany. This includes clinics and private practices as well as physio therapists and self-help groups. Additionally, 8 freelancers are care for the patients and provide support with the advice-intensive food drop system in domestic surroundings. Electrostimulation therapy has had a firm place in modern pain therapy for years and is a proven form of therapy in medical practices and clinics. We focus in particular on customer-friendly service for doctors and patients with technically high-quality and user-friendly devices for electrical stimulation and functional electrical stimulation (FES) in the following areas:

• Peroneal Nerve Stimulation
• Biofeedback Therapy
• Incontinence Therapy
• Stimulate Muscle Development
• Pain Management
• Corona Protective Equipment

As part of the company philosophy Competence and experience for a better quality of life we continuously develop innovative systems in the field of electromedicine. In cooperation with technical speakers and product specialists, device workshops are held for users, doctors and medical specialists and therapists. Certified advanced training events with modern presentation technology for clinics, doctors, practice staff, self-help groups and patients alike take place on a regular basis. Thanks to constant further development of the products, in particular functional electrical stimulation (FES), innovative and easy-to-use, wireless wireless foot lifter systems are successfully used since 2015 in treatment of patients with foot drop. Due to this technological lead, HELLER MEDIZINTECHNIK GmbH & Co. KG is one of the innovative world market leaders in the market segment of functional electrical stimulation (FES) with the innoSTEP-WL foot lift system. With his 35 years of experience in medical technology, Joachim Heller, as managing director of HELLER MEDIZINTECHNIK GmbH & Co. KG, with his committed team and innovative products, has successfully managed to use competence and experience to help patients achieve greater mobility and thus a higher quality of life. Since November 2020 he represents the company in the Senate of Economy Europe and Germany.

Succes story Corona Protective Equipment

Due to numerous trips to China and the resulting intensive good contacts to innovative manufacturers from Asia and decades of medical competence and experience, the portfolio was expanded with great success with Corona Protective Equipment. Right from the start of the corona pandemic in March 2020 until today, we offered the civilian population and systemically important institutions high-quality, CE-certified FFP2 masks. Thus, we could offercustomers were given a better quality of life and protection. In October 2020, our Corona products were successfully outsourced to the fulfillment service company weLOG GmbH Wetzlar due to high demand.

Expertise

We are prequalified in accordance with para. 1a of the SGB V (the German Social Code) by the German Society for Prequalification in Health Care (DGP®).

 

HELLER MEDIZINTECHNIK ist vom TÜV SÜD nach EN ISO 13485 zertifiziert

Wir sind nach EN ISO 13485 vom TÜV SÜD zertifiziert für Erbringung von Verkaufs-, Vermietungs-, Installations- und Reparaturdienstleistungen für medizinische Geräte im Bereich der Elektrostimulation sowie Verkauf von persönlicher Schutzausrüstung zum Infektionsschutz.

Die Norm EN ISO 13485 „Medizinprodukte: Qualitätsmanagementsysteme – Anforderungen für regulatorische Zwecke“ befasst sich mit den Anforderungen, die Hersteller und Anbieter von Medizinprodukten bei der Entwicklung, Umsetzung und Aufrechterhaltung von Managementsystemen für die Medizinproduktebranche erfüllen müssen. Die ursprünglich in den 1990er Jahren entwickelte Norm enthält Anforderungen an Qualitätsmanagementsysteme, die Kundenanforderungen, aber auch die regulatorischen Anforderungen der Europäischen Union (EU), Kanadas und anderer wichtiger Märkte weltweit erfüllen.

Die EN ISO 13485 ähnelt in ihrem Anwendungsbereich und Zweck der Norm ISO 9001. Sie enthält jedoch zusätzliche, spezifische Anforderungen für Medizinprodukte und formuliert manche Vorgaben der ISO 9001 um. In den meisten Märkten ist daher eine Zertifizierung nach ISO 9001 kein adäquater Ersatz für eine Zertifizierung nach den Anforderungen der EN ISO 13485.

In der EU wurden die Anforderungen der EN ISO 13485 mit den Anforderungen der EU-Medizinprodukterichtlinie (93/42/EWG), der Richtlinie über In-vitro-Diagnostika (98/79/EG) und der Richtlinie über aktive implantierbare medizinische Geräte (90/385/EWG) harmonisiert.