Regulatory Ready
Our Approach
Invetech’s regulatory ready manufacturing capability is built around ISO 13485 and ISO 9001 certified quality systems, FDA requirements, and decades of experience manufacturing complex diagnostic instruments for global healthcare leaders. This matters because in regulated markets, manufacturing is not simply about building products. It is about traceability, validation, documentation, quality control and ensuring products can reliably perform in real world clinical environments at scale.
By embedding manufacturing, supply chain and quality expertise early in development, Invetech helps customers design products that are easier to scale, more robust in production and faster to commercialise. The result is a smoother path from innovation to market, with fewer production surprises, reduced operational risk and stronger readiness for global regulatory and commercial requirements.
Why Invetech
Research, design, and validation in the same room.
Our UX team designs alongside the industrial design, software, and human-factors engineering teams that have to deliver on the experience. The design we research and prototype in week one is buildable, validatable, and submittable. Not a deliverable that gets quietly redesigned during integration. And because IEC 62366 alignment is the default, summative validation is something we plan for, not retrofit to.
Areas of Expertise
Reveal user needs and opportunity spaces through contextual and usability research
Imagine and design complete product visions, physical architectures and intuitive user interfaces that are styled according to existing or newly created brand design language, ready for manufacture
Design intuitive, branded digital experiences that seamlessly support the user and manage the broader system
Mitigate use‑related risks and generate documentation that adheres to FDA guidance and IEC 62366‑1 requirements
How the instrument’s tasks, screens, and physical interactions are organized into a workflow the user can hold in their head.
Client Outcomes
Explore strategic possibilities, define a purposeful vision and a path to realization
- Worfklow Transformation
- Co-creation Workshops
- Product & Feature Roadmapping
We partnered with Hologic to reimagine cervical cancer diagnosis user experience with an Al assisted digital cytology workflow
Image courtesy of HOLOGIC, Inc. and affiliates
Uncover unmet user needs and assess usability within healthcare environments
- Discovery Research
- Usability Evaluations
- Human Factors Engineering
Global molecular diagnostics client
We helped a health-tech business to iteratively design and test usability of a Point of Care device for use in multiple US healthcare settings.
Visualize ideas to inspire and align your stakeholders
- Digital Design
- Industrial Design
- Virtual Reality Experiences
Design Challenge
We imagined the future vision of a 2030 sepsis diagnosis laboratory
Design and deliver physical and digital offerings to your customers
- Interaction Design
- UI/UX (User Experience)
- Styling
We worked together with Leica Biosystems to desian, develop and realize the physical interactions and styling of the BOND-PRIME
Related Capabilities
Applications Labs
Device Master Record Management
Continuous Improvement & Lean Manufacturing
Value Analysis & Value Engineering
Design for Manufacture & Assembly
Electronics
Experience Design
Software
Strategic Program Management
Temperature Control
Systems Engineering
Product Lifecycle Management
Consumable Design
Fluidics
Robotics & Motion
Optics
Need help shaping your product vision?
From uncovering user needs to shaping product strategy, we create experiences that are human-centered, intuitive, and built to last.
