Diagnostics & Lab Systems

In vitro diagnostics (IVD) and point-of-care (POC) diagnostics

Helbling has more than 20 years’ experience developing automated laboratory equipment for clinical and molecular diagnosis. Our strength lies in cross-system development. Interdisciplinary teams comprising industrial designers, mechanical, electronic and software engineers interact with doctors, chemists, biologists and physicists. The focus is always on the combination of applications, consumables and devices.

Our development process is based on the provisions of IVD Directive 98/79/EC and (now) IVD Regulation 2017/476. Our development process is ISO 13485:2016-certified and FDA-compliant (21 CFR Part 820). The following norms and standards are also applied:

• IEC 62366: Usability engineering
• EN ISO 14971: Risk management
• IEC 61010: Safety regulations for laboratory equipment
• IEC 60601: Safety regulations for medical devices
• MDD 93/42/EEC: Medical devices directive
• GAMP5: Achieving compliant computerized systems

Biotechnology and Personalised Medicine

Helbling brings together specialists and scientists from various fields of life sciences, molecular and microbiology as well as laboratory experts.

We develop new devices, consumables, and assays, thus enabling new therapies and biological products. Applications and processes are subject to GMP or ATMP regulations. We provide our services in the following areas:

• Toxicology and Pharmacy
• Molecular Genetics
• Clinical Chemistry
• Chromatography and Spectrometry
• Haematology and Serology
• Molecular and Microbiology
• Human Medicine and Physiology

Laboratory systems for research and the life sciences

In keeping with the principle “Focused on quality, keeping costs in check”, we work together with our customers to develop systems that enable researchers to develop new therapies or treatment options, discover new active ingredients or conduct environmental or food analyses. As part of this, we employ innovative technologies coupled with fundamental expertise in the fields of optics, sensors, automation, separation, liquid handling, plastics technologies, tempering, etc.