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Before a medical device can receive market clearance, it must generate data demonstrating safety and performance. In many cases, that data comes from clinical investigation conducted under appropriate regulatory oversight.
So how do innovators move from prototype to patient responsibly?
When devices are used in clinical investigations, whether under an FDA Investigational Device Exemption (IDE), Institutional Review Board (IRB) oversight, or in international studies, the sterilization process must be scientifically justified, well documented, and appropriate for investigational use.
This is where Andersen Scientific plays a critical role.
ISO 11135 provides mechanisms for risk-based sterilization validation, including approaches suitable for limited or investigational device releases. While authorization to conduct clinical investigations comes through regulatory pathways such as IDE or IRB approval, the sterilization process must still demonstrate an acceptable sterility assurance level and support patient safety.
We design and document sterilization protocols that balance investigational device requirements with our clients’ understandable concern about device loss.
Clinical study devices are often:
- Hand-assembled
- Iterative in design
- Produced in very limited quantities
- High in individual unit cost
Every device matters.
Our team works directly with manufacturers to:
- Develop sterilization protocols appropriate for investigational use
- Minimize unnecessary product destruction during validation activities, including, where scientifically appropriate, reuse of devices for subsequent laboratory evaluations
- Coordinate third-party laboratory testing
- Manage timelines and reporting requirements
- Provide documentation to support IDE or IRB submissions
We understand that clinical investigations operate on tight timelines. Once a patient is enrolled, surgical dates are often fixed. In some cases, a delay in device availability can mean a patient is no longer eligible for treatment.
For time-sensitive studies, we offer an expedited clinical pathway with active project management, priority scheduling, and direct communication access. This level of engagement frequently extends beyond standard business hours, late into the night and through weekends, because clinical programs do not pause at 5 p.m.
Over the years, we have partnered with early-stage innovators as they progressed from first-in-human use to FDA clearance and beyond. Many companies that began as small development teams have grown into successful publicly-traded organizations. We are proud to have supported programs that have provided children with extended life and improved quality of life for patients facing debilitating neurological conditions.
Being part of that journey and helping ensure investigational devices reach patients safely and responsibly is one of the most meaningful aspects of our work.
At Andersen Scientific, we do not authorize clinical use. We make sure that when clinical devices are used, sterilization is performed correctly, defensibly, and without unnecessary risk.
