Life Science

Turning breakthrough science into robust devices is rarely straightforward. You might encounter these common challenges:

• Balancing development phases, making sure proof-of-concepts, feasibility studies and full-scale development each serve their purpose.
• Achieving smooth system integration, to avoid delays, higher costs and extra risks.
• Coordinating responsibilities across disciplines, ensuring microfluidics, optics, hardware and biotech evolve in sync from the start.
• Defining clear roadmaps, to bridge the gap between early prototypes and RUO or IVDR-compliant products.
• Finding the right level of engineering, futureproofing where it matters to keep the path to scaling open.

We act as a one-stop partner for device development in life sciences. While you can stay focused on your core technology, we take ownership of the engineering, architecture and integration. For highly specialized domains such as microfluidics, we collaborate with trusted partners and suppliers, but we remain accountable for the full system.

Because we understand both the research-driven RUO market and the regulated IVDR environment, we can tailor the development path to your roadmap. Sometimes that means building lean RUO devices, other times it means designing for IVDR compliance from day one. Our compliance experts ensure you don’t over-engineer where it’s not needed and don’t under-prepare for new regulatory milestones.

Experience with recurring challenges - like automating liquid handling assays, optical integration and microfluidics - help us move faster and avoid reinventing the wheel. The result? Your devices are functional in the lab, manufacturable at scale and future ready.

Life sciences devices face a dual reality: Research Use Only (RUO) development, where speed and lean certification matter, and IVDR development, where compliance is non-negotiable. Our team has experience with both.

Starting from the intended use, the device can be identified as medical, in vitro diagnostic (IVD) or RUO device under the low voltage directive. Medical and IVD devices demand a further classification to determine the need for involvement of a notified body as part of the certification process. For devices used in pharmaceutical settings, such as quality control on medicinal products, Good Manufacturing Practices (GMP) are additionally considered.

After defining the legal framework, requirements are extracted from all relevant standards harmonized under the applicable directives. Common standards in the life sciences field include:

• EN IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use
• EN IEC 61010-2-XX Safety requirements for device functionalities and elements such as lasers, heating, ...
• EN IEC 61326-1 Electrical equipment for measurement, control and laboratory use - EMC requirements
• Low Voltage Directive (LVD) 2014/35/EU
• ISO 13485 – Quality management for medical devices
• IEC 62304 – Medical device software life cycle processes
• 21 CFR Part 11 – Software validation and electronic records