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Research & Development

Developing new / innovative and superbly efficient products is the goal of any R&D department for a medical device. During the R&D phase, although innovation and product development are the focus, but quality and compliance remain critical.

R&D practices should ensure an outstanding product design which encompasses manufacturability and guarantees quality and compliance. It is crucial in maintaining an untouched leader status as an innovator with an eye towards the regulatory compliance. Detecting where opportunities lie while nurturing products the cost effective way will provide the profits necessary to keep the organization on top and customers truly satisfied.

We provide the following consulting services:

New product design and development

  • Support class I – class III device design and development process as per EU (CE mark), US (510(k), IDE, PMA), Australia, Canada, and Japan requirements.

Verification and validation testing (V&V)

  • Identify and recommend design verification & validation testing requirements.

Coordinate and conduct V&V testing

We will coordinate and conduct V&V testing:

  • Identify contract laboratories and manage the testing.
  • Technical analysis of the results.
  • Write protocols and reports.

Prototyping and concept development

  • Evaluate new design concepts
  • Build prototypes
  • Working with client to devise an iterative device development.
  • Offer guidance on equipment, materials and resources.