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Concept Development
Medical device concept development and initial design ideation.
Product Development & R&D Support for Pharmaceutical Companies — from concept through prototype and testing.
We also provide engineering design and research & development support for pharmaceutical and medical-device projects.
Through our collaboration with a pharmaceutical university and associated academic/research facilities in India, we can support companies interested in developing, testing, and validating new medical or pharmaceutical-related devices.
This collaboration provides access to specialized facilities and technical resources that can support projects beyond the initial engineering design stage.
Medical device concept development and initial design ideation.
Detailed 3D models for medical devices and components.
Engineering support through to prototype fabrication.
Access to testing facilities through our university collaboration.
One engineering team takes your medical or pharmaceutical device from first requirements through testing, manufacturing and launch, with feedback loops built in at every stage.
Our medical-device engineering processes are structured in alignment with ISO 13485:2016 and applicable medical-device regulatory requirements.
How the standards fit together
What each standard means for your project
Medical devices — Quality management systems — Requirements for regulatory purposes
What this means for your project
Medical devices — Application of risk management to medical devices
What this means for your project
Biological evaluation of medical devices
What this means for your project
Clinical investigation of medical devices for human subjects — Good clinical practice
What this means for your project
General requirements for the competence of testing and calibration laboratories
What this means for your project
Depending on the project requirements, our university collaboration can also provide access to facilities and technical support for applicable pre-clinical and clinical research activities in India, subject to the required regulatory approvals, ethics approvals, institutional requirements, and applicable Indian regulations.
If your pharmaceutical or healthcare company has an idea for a new medical device or requires engineering support for an existing product, we can help develop the project from the engineering stage and coordinate with our academic/research partners where appropriate.
Talk to Us About Your Project