Question 1

Why bundle instead of doing them one at a time?

Accepted Answer

Roughly 70% of the controls overlap. Doing them sequentially means re-collecting the same evidence four or five times - and pushing your hospital and EU launch out 9-18 months. Parallel tracks compress that to a single program.

Question 2

Do you do the SOC 2 audit and HITRUST validated assessment yourselves?

Accepted Answer

We run readiness, control build, and evidence collection. The SOC 2 Type II audit is performed by a partner CPA firm, and HITRUST validated assessments by an authorized HITRUST External Assessor. We coordinate both - you get one project, not three vendors.

Question 3

Which HITRUST level should I start with?

Accepted Answer

Most pre-revenue MedTech innovators start with HITRUST e1 (Essentials, 1-year). Once you have hospital traction, step up to i1, then r2 if a large IDN requires it. We'll recommend a path based on your target HDOs.

Question 4

What does the GDPR track cover?

Accepted Answer

Article 30 Records of Processing, Article 32 technical and organizational measures, Article 35 DPIAs for high-risk processing, data-subject rights workflows, breach notification (Article 33/34), international data transfer mechanisms (SCCs), and a Data Processing Agreement template. If you're processing EU patient data - including via a hospital partner - you need this before launch.

Question 5

When should I start this relative to my FDA submission?

Accepted Answer

Ideally 6-9 months before your FDA submission lands. That puts SOC 2 Type II coverage, HIPAA risk analysis, and GDPR documentation in hand the same month you receive clearance - so US procurement and EU market access start immediately, not after another 12 months of audit work.

Question 6

Is this only for SaMD or also for connected hardware devices?

Accepted Answer

Both. SaMD usually leans heavier on SOC 2 + HIPAA + GDPR cloud controls; connected hardware leans heavier on FDA cybersecurity + HITRUST device controls. The bundle adjusts the depth of each track to match.

Question 7

What does the bundle cost compared to running each program separately?

Accepted Answer

Running SOC 2 Type II, HIPAA, HITRUST e1/i1, and GDPR as four separate engagements can duplicate effort across engagements because each vendor re-collects evidence, re-writes policies, and re-builds an evidence vault. The bundle delivers all four (plus the FDA-cybersecurity crosswalk) under a scoped fixed fee because the control set, policy library, evidence vault, and project manager are shared. The savings get larger the more frameworks you add - the marginal cost of the fourth or fifth attestation is small once the first is built.

Question 8

How does this bundle reduce FDA submission risk specifically?

Accepted Answer

FDA reviewers increasingly ask whether the manufacturer has the organizational maturity to operate the cybersecurity controls described in the submission. A live SOC 2 Type II report, HIPAA program, and HITRUST level (where applicable) is concrete evidence that those controls exist and are operating - not just promised. We package the relevant excerpts as a 'cybersecurity capability' appendix to the submission so the reviewer doesn't have to ask. Several of our clients have used this to defuse RTA holds and AIRs in pre-submission feedback.

Question 9

Who owns the evidence vault and policies after the engagement ends?

Accepted Answer

You do, fully. We deliver the policy library, evidence vault structure, control narratives, crosswalk matrix, and audit-coordination runbooks in your tooling (Vanta, Drata, SecureFrame, or a hardened SharePoint/Confluence setup if you prefer to avoid GRC tooling). The deliverables are designed for your team to operate independently afterward - we are not trying to lock you into ongoing managed services. Most clients keep us on a small retainer for the first annual cycle, then run it themselves.

Question 10

What's the annual maintenance burden after the first cycle?

Accepted Answer

Plan on roughly 0.5-1.0 FTE of internal time per year across security, engineering, and operations to keep evidence current, complete the SOC 2 Type II re-audit, refresh HITRUST evidence, and run the HIPAA quarterly internal evaluations. GDPR requires an annual review of the RoPA and DPIAs. We provide a quarterly cadence calendar and review-meeting templates so the work is predictable and avoidable last-minute audit scrambles disappear. If the team is too small to absorb the work, we offer a Compliance-as-a-Service retainer at a fixed monthly fee.

Control area	FDA	SOC 2	HIPAA	HITRUST	GDPR
Risk assessment & threat modeling ISO 14971 + ANSI/AAMI SW96 patient-safety threat model, reused as the SOC 2/HIPAA/HITRUST risk assessment and the GDPR Art. 35 DPIA input.
Policies & procedures (SDLC, change, IR) One policy set: SDLC, change management, incident response, vendor management. Mapped to each framework's policy requirements.
Access control & identity Least privilege, MFA, role-based access, joiner/mover/leaver - one control, five attestations.
Encryption (at rest & in transit) TLS 1.2+, KMS-backed key management, documented for FDA crypto rationale, SOC 2/HIPAA/HITRUST controls, and GDPR Art. 32 technical measures.
SBOM + vulnerability management FDA-aligned SBOM (SPDX/CycloneDX) + continuous CVE monitoring becomes the SOC 2 vuln-mgmt and HITRUST patching evidence.
Penetration testing One white-box test campaign satisfies FDA premarket testing, SOC 2 CC4.1, HIPAA evaluation, HITRUST 10.b, and GDPR Art. 32 testing of effectiveness.
Logging, monitoring, & alerting Centralized logs with 1-year retention, alerts for security events. Reused across SOC 2 CC7, HIPAA audit controls, HITRUST 09.aa.
Incident response & breach notification One IR runbook covering FDA postmarket reporting, SOC 2 incident process, HIPAA breach notification, HITRUST 11, and GDPR Art. 33/34 (72-hour DPA notification).
Vendor / Business Associate management BAAs, DPAs, vendor risk reviews, and SBOM upstream evidence - one register, five frameworks.
Workforce training & awareness Annual security + HIPAA + GDPR training tracked in one LMS, evidence reused across SOC 2, HIPAA, HITRUST, GDPR.
Postmarket vulnerability disclosure Coordinated VDP and CVE handling required by FDA 524B - reused as the SOC 2/HITRUST vuln-disclosure control.
Data subject rights & records of processing GDPR Art. 30 RoPA, Art. 12-22 data-subject request workflow, Art. 35 DPIAs, and international transfer mechanisms (SCCs). Doubles as HIPAA right-of-access evidence.
Audit-ready evidence repository One evidence vault: FDA eSTAR attachments, SOC 2 fieldwork pulls, OCR/HHS audit, HITRUST MyCSF uploads, GDPR Art. 5(2) accountability records.

Control area	FDA	SOC 2	HIPAA	HITRUST	GDPR
Risk assessment & threat modeling ISO 14971 + ANSI/AAMI SW96 patient-safety threat model, reused as the SOC 2/HIPAA/HITRUST risk assessment and the GDPR Art. 35 DPIA input.
Policies & procedures (SDLC, change, IR) One policy set: SDLC, change management, incident response, vendor management. Mapped to each framework's policy requirements.
Access control & identity Least privilege, MFA, role-based access, joiner/mover/leaver - one control, five attestations.
Encryption (at rest & in transit) TLS 1.2+, KMS-backed key management, documented for FDA crypto rationale, SOC 2/HIPAA/HITRUST controls, and GDPR Art. 32 technical measures.
SBOM + vulnerability management FDA-aligned SBOM (SPDX/CycloneDX) + continuous CVE monitoring becomes the SOC 2 vuln-mgmt and HITRUST patching evidence.
Penetration testing One white-box test campaign satisfies FDA premarket testing, SOC 2 CC4.1, HIPAA evaluation, HITRUST 10.b, and GDPR Art. 32 testing of effectiveness.
Logging, monitoring, & alerting Centralized logs with 1-year retention, alerts for security events. Reused across SOC 2 CC7, HIPAA audit controls, HITRUST 09.aa.
Incident response & breach notification One IR runbook covering FDA postmarket reporting, SOC 2 incident process, HIPAA breach notification, HITRUST 11, and GDPR Art. 33/34 (72-hour DPA notification).
Vendor / Business Associate management BAAs, DPAs, vendor risk reviews, and SBOM upstream evidence - one register, five frameworks.
Workforce training & awareness Annual security + HIPAA + GDPR training tracked in one LMS, evidence reused across SOC 2, HIPAA, HITRUST, GDPR.
Postmarket vulnerability disclosure Coordinated VDP and CVE handling required by FDA 524B - reused as the SOC 2/HITRUST vuln-disclosure control.
Data subject rights & records of processing GDPR Art. 30 RoPA, Art. 12-22 data-subject request workflow, Art. 35 DPIAs, and international transfer mechanisms (SCCs). Doubles as HIPAA right-of-access evidence.
Audit-ready evidence repository One evidence vault: FDA eSTAR attachments, SOC 2 fieldwork pulls, OCR/HHS audit, HITRUST MyCSF uploads, GDPR Art. 5(2) accountability records.

FDA, SOC 2, HIPAA, HITRUST, GDPR. One program. Parallel tracks.

Can one program cover FDA, SOC 2, HIPAA, HITRUST and GDPR?

Why MedTech innovators stall after FDA clearance

Procurement freezes the deal

Duplicated work, duplicated cost

Frameworks don't speak to each other

One control set. Five attestations.

How the bundled program runs

1. Crosswalk & gap assessment

2. Control build (parallel)

3. Evidence + testing

4. Attestations & submission

Reviewer-ready deliverables in one engagement

Explore each compliance track

SOC 2 Type II for MedTech

HITRUST Readiness (e1 / i1 / r2)

GDPR for Connected Medical Devices

HIPAA Compliance Program for MedTech

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MedTech Compliance Bundle FAQs

MedTech Compliance Bundle - scoped, fixed-fee, FDA-ready.

One control set. Five attestations.