Predetics services

Medical device software and regulatory services.

Choose a specific service or ask us to combine software, evidence, quality and regulatory work in one project.

Selected clients

Healthcare teams we have supported

Engineering

Medical Device Software Development

Design, build and document SaMD under a controlled software lifecycle.

Threat modelling, SBOM, testing and lifecycle evidence for FDA review.

FDA pathways

Classification, strategy, FDA engagement and submission support.

Predicate strategy, substantial equivalence and complete submission support.

Risk controls and evidence for novel low- to moderate-risk devices.

Global regulatory

Rule 11 classification, technical documentation and notified-body support.

Classification, licensing and documentation for the Indian market.

Evidence and lifecycle

Clinical evaluation strategy, literature review and performance evidence.

Use-related risk, formative work and validation planning for SaMD.

PMS, PMCF, vigilance and lifecycle evidence after market entry.