Regulatory consulting for FDA, HIPAA, NIST, and quality-system programs

Service · Regulatory Consulting

A named engineer, not a slide deck: FDA regulatory strategy across the 510(k), PMA, and De Novo pathways, HIPAA compliance program design, quality management system build-out (CAPA, document control, internal audit), NIST and FedRAMP authorization support, and ISO 14971 risk management — each engagement produces documentation a reviewer can actually act on, not a recommendations report with no implementation behind it.

What does Netspective regulatory consulting cover?

It covers FDA strategy across the 510(k), PMA, and De Novo pathways, HIPAA program design, quality management system build-out, NIST and FedRAMP authorization support, and ISO 14971 risk management. Each engagement produces documentation a reviewer can act on, delivered by a named engineer.

Four commitments that hold across every engagement

FDA Strategy: 510(k), PMA, and De Novo pathway selection grounded in device classification and predicate history.
Quality System Design: QMSR/ISO 13485 quality systems built for audit, not assembled after one is scheduled.
Risk Management: ISO 14971 risk files linked to verification records, not maintained as a standalone binder.
Submission Traceability: Requirement-to-evidence traceability a federal reviewer can actually follow.

Regulatory frameworks we specialize in

FDA QMSR (21 CFR 820)
ISO 13485
ISO 14971
IEC 62304
HIPAA
NIST SP 800-53
FedRAMP
SOC 2

ARCH-SPEC 01: Regulatory Submission Readiness Architecture

FDA QMSR / 21 CFR 820 ISO 14971 DETERMINISTIC VERIFICATION

Six regulatory programs

FDA Regulatory Pathways

510(k), PMA, and De Novo submission strategy mapped to a specific device classification and predicate history.

510(k) Predicate Analysis
PMA Clinical Strategy
De Novo Classification
Pre-Submission (Q-Sub) Meetings

QMS Design (QMSR / ISO 13485)

Quality management system build-out under the FDA QMSR harmonization with ISO 13485, from document control to internal audit. See FDA QMSR Design Controls for the governing standard.

Design Controls (ISO 13485:2016 §7.3 / former 21 CFR 820.30)
Document Control
CAPA Process Design
Internal Audit Program

ISO 14971 Risk Management

Risk management files built to ISO 14971:2019, linked to verification records instead of maintained as a standalone binder.

Risk Management Plan
Hazard Analysis
Risk Control Verification
Residual Risk Evaluation

Technical Documentation (DHF/DMR)

Design history files and device master records structured for reviewer traceability, not reconstructed after a design freeze.

Design History File (DHF)
Device Master Record (DMR)
Design Traceability Matrix
Change Control Records

HIPAA Compliance Programs

HIPAA Security Rule compliance program design — administrative, physical, and technical safeguards mapped to an organization's actual systems. See HIPAA Engineering Practices.

Security Risk Assessment
Business Associate Agreements
Breach Notification Procedures
Workforce Training Program

NIST & FedRAMP Authorization

Federal authorization support across NIST SP 800-218 SSDF and FedRAMP, from control mapping through continuous monitoring.

NIST SSDF Control Mapping
FedRAMP SSP Authoring
Continuous Monitoring Setup
POA&M Management

SOC 2 TYPE 1 & 2 CERTIFIED FDA QMSR / 21 CFR 820 ISO 14971 HIPAA SECURITY RULE

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Discuss which regulatory program applies to a specific engagement.

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Engineering reference only. Not formal regulatory counsel. Consult your own quality system and legal counsel for a specific regulatory determination.

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