Regulatory & Quality
In addition to speed and value, quality ranks first in the minds of our customers. While other contract development and manufacturing firms continue to focus on nonintegrated single-discipline units, MedVenture maintains multi-disciplined, cross-functional teams to ensure that customers’ products receive the greatest consistency of knowledge and leveraged expertise. Products will have the same Quality Engineers from design control through ongoing manufacturing support. Additionally, the customer is involved and approves of all design changes throughout the product lifecycle.
MedVenture’s comprehensive quality program accommodates large and small companies to provide an array of services including:
- A dedicated team to perform and validate testing
- Same-day turnaround inspection capabilities during product design and product manufacturing
- Complete supplier management and performance tracking
- Product microbiology monitoring capabilities including dose audit, bioburden, LAL, ETO residual and sterility revalidation, and an established network for sterility and biological testing to expand our internal resources
- Monthly quality system monitoring, process monitoring, and product complaint evaluation
- Assistance with U.S. regulatory requirements (PMA, IDE, etc.) and tech file development for CE marking