Accelerating Class III Device Approval through Validated In Silico Evidence
Providing the high-fidelity computational modeling and ASME V&V 40 compliance required for BCI, Implantables, and Wearable safety validation.
- In Silico V&V
- HPC Infrastructure
- ASME V&V 40 Compliance
Validated Regulatory Evidence
Mehor Solutions provides specialized Regulatory Evidence for the MedTech industry. We bridge the gap between complex electromagnetic R&D and formal FDA submission through high-fidelity simulation and rigorous verification frameworks.
At Mehor Solutions, we provide high-fidelity electromagnetic modeling for mission-critical MedTech applications. From active implantables to complex wearables, we deliver the validated In Silico evidence required to bridge the gap between initial R&D and formal FDA submission.
Clinical Application Expertise
Specialized electromagnetic verification for active medical devices, ensuring safety and performance compliance in the most complex human environments.
Implantables & Wearables
We specialize in the verification of active implantables (BCI, Cardiac, Neuro) and wearable devices. Using high-fidelity Voxel meshes, we ensure electromagnetic safety, link budget reliability, and thermal compliance in the presence of the human body.
In Silico Design Verification
Utilizing a dedicated 2TB RAM HPC Cluster, we perform risk-informed computational modeling to confirm your device meets all electromagnetic specifications and safety margins before physical prototyping.
Regulatory Compliance (ASME V&V 40)
Our simulation workflows adhere to the ASME V&V 40 standard. We generate the validated technical artifacts, sensitivity studies, and worst-case analysis required for formal regulatory submissions.
Collaborated with Industry Leaders & Innovative Startups
OSCOR | CAPRI MEDICAL | SYNKOPI
VALENTIUM | RF EXPOSURE LAB | ASU
Engagement Workflow
Step 1:
Initial Assessment
Submit a brief regarding your device type and regulatory timeline. We will conduct a preliminary review to ensure alignment with our technical capabilities.
Step 2:
Technical Strategy Session
A deep-dive consultation between our Principal Engineer and your technical leads. We establish an NDA and define the specific In Silico evidence required for your project.
Step 3:
Scope & V&V Framework
We provide a detailed proposal outlining the computational resources (HPC), modeling methodology, and the ASME V&V 40 framework to be applied.
Step 4:
Project Initiation
Upon agreement of terms, we integrate with your R&D timeline to begin generating the validated electromagnetic evidence needed for your submission.