Device master record management
We standardized documentation and shared processes to support a more seamless transfer into manufacturing reducing overhead for our clients.
Our Approach
Managing documentation (including Device Master Records and Device History Records) plays a critical role in moving products into stable, controlled manufacturing. Clear, accurate and well managed documentation supports consistency on the production floor, strengthens traceability and helps reduce the risk of errors during transfer, scale up and ongoing operations. At Invetech, we treat documentation as an essential part of manufacturing readiness, not just an administrative requirement – every document must add value.
Our teams create and maintain structured records that support repeatability across materials, assemblies, , equipment, test methods and production processes. That gives customers greater confidence that the information needed to build, inspect and support the product is complete, controlled and aligned across functions. In regulated environments, this level of discipline is especially important because documentation quality directly affects execution, compliance and change control.
By bringing engineering, quality and manufacturing together around a disciplined documentation process, Invetech helps customers create a smoother transfer into production and a stronger platform for long term support. The result is better control, clearer communication and a manufacturing environment that is more prepared to scale and adapt over time.
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
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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
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We worked together with Leica Biosystems to desian, develop and realize the physical interactions and styling of the BOND-PRIME
Related Capabilities
Continuous Improvement & Lean Manufacturing
Value Analysis & Value Engineering
Design for Manufacture & Assembly
Regulatory Ready
Electronics
Strategic Program Management
Temperature Control
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.