Premium · PE & VC

MedTech Technical Due Diligence

No career consultant can provide BLE/hardware layer and LLM/cloud infrastructure assessment in one engagement. We can — because our founding team has shipped a live clinical-device platform where a BLE stack streams to an LLM-powered cloud. The seam between hardware and software is where MedTech investments actually fail; that's exactly where we look.

PE firms — pre-acquisitionPE firms — 100-day post-acquisitionVC firms with MedTech portfoliosMedTech raising Series B+
5–6 weeksStandard timeline
Custom-scopedContact us for a quote
Category of oneHardware + cloud, one engagement

Delivery Phases

Hardware, software, and the seam between them.

Weeks 1–2 · Phase 1

Hardware & Device Layer

BLE stack, firmware architecture, device-to-cloud pipeline, continuous streaming vs. read-only capability, and regulatory posture — FDA 510(k), CE, MDR.

Weeks 3–4 · Phase 2

Software & Cloud Layer

LLM/AI infrastructure, model governance, data privacy posture, cloud architecture, cost structure, and HIPAA/SOC 2/GDPR compliance review.

Weeks 4–5 · Phase 3

Integration & Risk Register

How hardware data flows to software — the highest-risk seam in any connected-device platform. Delivered as an investment risk register, tiered by severity, with remediation cost estimates and executive synthesis.

Why This Exists

Comparable engagements cost $60K–$90K across two separate consultants.

Hardware due diligence and software/cloud due diligence are normally two separate engagements with two separate consultants who don't talk to each other — which means the integration risk, the actual seam where devices fail in the field, goes unexamined. We run both in one engagement, with one team.

Urgency timelines available

If your deal timeline requires a 3–4 week turnaround instead of the standard 5–6 weeks, we can compress the schedule — deep-layer hardware forensics done faster, not skipped. Ask us for details.

Confidentiality first

NDA and authorized-personnel schedules in place before any data is shared.

Every diligence engagement follows a strict confidentiality protocol from the first document request.

Book a 20-min consult