Sigma Industry LifeTech is our specialized offering within Life Science and MedTech created to develop the next generation of products and solutions in an industry where quality, precision, and regulatory compliance are essential.

We deliver end-to-end development projects within medical technology, digital health, and solutions for the pharmaceutical industry – from early concepts and ideas to verification, validation, and industrialization. With us, you gain a partner who understands the entire journey.

Whether you need support in a specific phase or are looking for a long-term development partner, we adapt to your needs. Our cross-functional teams cover the full development lifecycle from needs analysis and risk management to design, engineering, electronics, software, and documentation, all the way to market approval in accordance with ISO 13485, MDR, and FDA requirements.

What sets us apart is our combination of cutting-edge engineering expertise, deep understanding of quality systems and regulatory frameworks, and strong capabilities in production engineering. This creates a solid foundation for developing safe, sustainable, and market-ready products.

We work in fast, iterative cycles within advanced prototyping and test environments where ideas quickly become reality. Together with our production and assembly partners, we ensure a seamless transition from prototype to full-scale production – regardless of volume. From first idea to finished product.

Sigma LifeTech is built for growth. We are continuously expanding our capabilities, strengthening our customer partnerships, and taking on new, complex challenges across the Life Science and MedTech landscape.

As part of the Sigma Group, we combine the strengths of multiple companies, enabling us to offer a broad range of competencies and scalable, global delivery capabilities. Through established partnerships and framework agreements with leading companies, we support our customers wherever they operate.

We develop tech for life for a better tomorrow.

SIMULATION & CAE
We offer advanced simulation services within Life Science and MedTech, focusing on product development, comfort optimization, and prototyping across a wide range of biomechanical and medical technology products, supporting the entire development process from concept to final solution.
With expertise in leading CAE tools, we perform analyses in areas such as fit, structural integrity, durability, and vibration, including advanced Human Body Models (HBM) with extensive tissue libraries for realistic simulations. With in-house HPC capabilities, we take responsibility for the entire workflow—from model development and simulation to validation and delivery of reliable results.

RA/QA
We have broad expertise in Regulatory Affairs and Quality Assurance from strategy and compliance to certification and quality management systems. We ensure regulatory compliance throughout the entire development lifecycle, with expertise in MDR and IVDR, working according to ISO 13485 and ISO 9001 to secure timely approvals, high quality, and patient safety.

MECHANICAL ENGINEERING
We offer cutting-edge expertise in mechanical development and CAD, with a particular focus on Life Science and MedTech, where quality, precision, and intelligent design are critical. Our engineers work both on-site with clients and in in-house projects, developing solutions that take products all the way from concept to final design.

UX & 3D DESIGN
We create user experiences and design that make advanced technology intuitive and valuable, especially within Life Science and MedTech. From needs analysis and user research to concept design and usability, we develop solutions that work in real life. With strong design expertise, we combine function, form, and regulatory requirements to create products that feel right and meet high standards.

LABORATORY ENGINEERING
We support development within Life Science and MedTech through reliable testing of product performance and physical properties. With expertise in material analysis, testing methods, and method development, we conduct qualified tests that ensure performance, durability, and usability. Our testing is often used for validation, as well as for building and calibrating methodologies in close interaction with simulation—enabling more accurate and predictive models. We manage the entire testing process—from planning and execution to quality assurance and delivery of clear, decision-supporting results—in accordance with relevant standards and regulatory requirements.

PROJECT MANAGEMENT
Project management is a core part of our LifeTech offering. Our project and technical leaders ensure that development targets are met on time and with the right quality. We lead projects throughout the entire process – from concept and prototyping to testing and final delivery.