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

Case Study: Supporting Cardiopulmonary Device Development with Validation Expertise

Client Challenge
A leading medical device company developing a cardiopulmonary device required additional support in the design, development, and validation of their new product. As the client abides by ISO 13485 regulations, ensuring compliance and rigorous validation throughout the product lifecycle was a top priority.

Viltis Solution
Chosen as a strategic partner, Viltis delivered a specialized team of 16 consultants with deep expertise in medical device development and validation.

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

• Validation Specialists with expertise in equipment, process, and software validation aligned with ISO 13485 requirements.
• Mechanical, Electrical, and Systems Engineers experienced in cardiopulmonary technologies.
• Expertise in 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 ISO 13485 standards.
• 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.
• IP Contribution: Supported the client’s intellectual property strategy through invention and patent applications.
• Project Management: Provided technical leadership, resource planning, scheduling, and cross-department coordination to ensure project milestones were met.

Engagement Model
The team was structured to work remotely during the initial phase and was prepared to transition to on-site support once client operations resumed in office.

Outcome
Through its emphasis on 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.