Assembly Manufacturing:
Regulatory, Quality and Sterilization
Quality, speed and value are critically important to our customers. While other contract development and manufacturing firms focus on nonintegrated, single-discipline units, MedVenture maintains multi-disciplined, cross-functional teams to ensure customers’ products receive the benefits of consistent and leveraged expertise. Additionally, the customer is involved and approves of all design changes throughout the product lifecycle.
MedVenture’s comprehensive quality program provides services for companies of all sizes. Services include:
- A dedicated team to perform and validate testing
- Efficient 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 capabilities
- Monthly quality system monitoring, process monitoring and product complaint evaluation
- Assistance with U.S. regulatory requirements and tech file development for CE marking
