Design and Development Support for Abbott's Cardiovascular Division II

Supporting Cardiopulmonary Device Development with Validation Expertise

A medical device company developing a cardiopulmonary product needed extra support in design, development, and validation. Compliance and rigorous validation through the product lifecycle were non-negotiable.

Viltis delivered a team with medical device development and validation experience, including

Validation engineers familiar with equipment, process, and software validation.

Mechanical, electrical, and systems engineers with cardiopulmonary background, including centrifugal pumps, fluidics, gas systems, and EPGS.

Key contributions

Developed and executed IQ/OQ/PQ validation protocols so equipment and processes met both regulatory requirements and client specifications.

Followed design control procedures so design plans, documents, and test protocols stayed aligned with applicable requirements.

Ran testing with existing protocols and newly written ones where the system needed something custom.

Worked with R&D, Quality, and Manufacturing to introduce new products and improve existing processes.

Supported invention and patent application work tied to the client's intellectual property strategy.

Provided technical leadership, resource planning, scheduling, and cross-department coordination against project milestones.

The team started remotely and was ready to move onsite once the client's office operations resumed. The work kept the cardiopulmonary device moving through critical development milestones under ISO 13485 expectations.