Regulatory and testing support for medical device manufacturing
Biocompatibility, transit, sterile barrier and sterilization validation testing coordinated for you, plus regulatory guidance on FDA clearance pathways, human factors and 510(k) submissions from people who have done it.
UTP Solutions supports medical device companies through the testing and regulatory work that surrounds manufacturing, not just the parts. UTP coordinates biocompatibility testing, transit and distribution testing, sterile barrier package testing and sterilization validation through qualified labs, and provides regulatory guidance on FDA clearance pathways, summative validation, human factors and 510(k) review. UTP's President has personally submitted 510(k)s, and UTP can support a submission directly or bring in a regulatory consultant when a program needs one.
Testing we coordinate
| Biocompatibility | Biological evaluation testing to ISO 10993, coordinated through qualified labs |
|---|---|
| Transit and distribution | Package transit and distribution testing to ISTA and ASTM D4169 test methods |
| Sterile barrier | Sterile barrier system and package integrity testing to ISO 11607 |
| Sterilization validation | Support for EtO and gamma sterilization validation with qualified sterilization providers |
| Process validation | IQ / OQ / PQ for molding, machining, assembly and packaging processes at UTP |
Regulatory guidance
FDA pathway strategy
Guidance on the right clearance pathway for your device and what the evidence package needs to include, before you commit to tooling and testing.
Human factors and summative validation
Support for human factors planning and summative validation, informed by OEM-side experience bringing devices through usability work and launch.
510(k) review and preparation
Review of your 510(k) content, or preparation support from UTP's President, who has submitted 510(k)s, or from a regulatory consultant we bring in.
Why it matters for emerging medtech
Most early-stage device companies don't have a regulatory team yet, and most contract manufacturers stop at the part. That leaves founders coordinating labs, sterilizers and consultants on their own while trying to hit a launch date.
- Testing planned with manufacturing. Test samples come from validated processes, so results reflect the parts you will actually sell.
- Fewer handoffs. One partner coordinates parts, packaging, sterilization and the testing that proves them.
- Experience from the OEM side. Guidance comes from people who have managed design controls, human factors and 510(k) submissions as the device company.
- Scaled to your program. Use as much or as little support as you need, from a 510(k) review to full coordination.
Regulatory and testing questions
Does UTP coordinate biocompatibility testing?
Yes. UTP coordinates ISO 10993 biocompatibility testing through qualified labs, along with transit, sterile barrier and sterilization validation testing.
Can UTP help with a 510(k)?
Yes. UTP provides 510(k) review and can support preparation directly through its President, who has submitted 510(k)s, or by bringing in a regulatory consultant.
Does UTP support human factors and summative validation?
Yes. UTP provides guidance on human factors and summative validation planning for medical devices.
Does UTP support sterilization validation?
Yes. UTP supports EtO and gamma sterilization validation through qualified sterilization providers and coordinates routine sterilization for production.
Do we have to use UTP's regulatory support to manufacture with UTP?
No. Regulatory and testing support is optional and scaled to what your team needs.
Talk to an engineer, not a call center.
Tell us about your device and where you are in development. A UTP engineer replies within two business days.