Design and Development Support for Abbott's Cardiovascular Division II

Case Study: Design and Development Support for Abbott’s Cardiovascular Division

Case Study: Supporting Cardiopulmonary Device Development with Validation Expertise

A leading medical device company developing a

required additional support in the

design, development, and validation

of their new product. As the client abides by

, ensuring compliance and rigorous validation throughout the product lifecycle was a top priority.

, Viltis delivered a specialized team of

with deep expertise in medical device development and validation.

Our consultants brought a broad range of technical and regulatory capabilities, including

• with expertise in equipment, process, and software validation aligned with
• Mechanical, Electrical, and Systems Engineers
• experienced in cardiopulmonary technologies.
• centrifugal pumps, fluidics, gas systems, and EPGS
• Key Contributions by the Viltis Team

Validation Leadership

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

Design Control Compliance

Followed stringent design control procedures to ensure all design plans, documents, and test protocols complied with

Custom Testing Solutions

Conducted testing using both existing test protocols and newly developed protocols to address unique system challenges.

Cross-Functional Collaboration

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

Supported the client’s intellectual property strategy through invention and patent applications.

Provided technical leadership, resource planning, scheduling, and cross-department coordination to ensure project milestones were met.

The team was structured to work remotely during the initial phase and was prepared to transition to

once client operations resumed in office.

validation excellence and ISO 13485 compliance

, Viltis ensured the client’s cardiopulmonary device advanced successfully through critical development milestones, supporting both innovation and regulatory readiness.