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FDA-Ready Data Infrastructure for Medical Device Companies

HV|MedTech™ delivers the connected data foundation medical device companies need for regulatory compliance. From Design History Files to post-market surveillance, built on Quickbase with Section 524B cybersecurity requirements in mind.

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The Regulatory Data Challenge

Medical device companies face mounting pressure from regulators, auditors, and customers to demonstrate complete data traceability.

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DHF Gaps

Design History Files scattered across SharePoint, email, and local drives create audit nightmares

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Cybersecurity

Section 524B requires SBOM documentation and vulnerability management you can't fake

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QMSR Transition

New FDA quality system regulation requires process-based QMS aligned with ISO 13485

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CAPA Chaos

Complaints, CAPAs, and nonconformances in disconnected systems obscure root causes

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Supplier Risk

Component traceability from supplier to patient is required but impossible to demonstrate

A System Built for Regulated Industries

HV|MedTech™ provides the connected data infrastructure that makes FDA compliance achievable—not just documentable. Every application links to the others, creating the complete traceability regulators expect.

Six Integrated Applications

Each module works standalone or connects to create end-to-end regulatory compliance.

Design History File (DHF)
21 CFR 820.30 Compliance
  • Design input/output tracking
  • Verification & validation records
  • Design review documentation
  • Risk management integration
  • Design transfer records
SBOM Management
Section 524B Compliance
  • Software Bill of Materials
  • Vulnerability tracking (CVE)
  • Patch management workflow
  • FDA submission packages
  • Lifecycle update tracking
Supplier Quality
Component Traceability
  • Approved supplier list (ASL)
  • Supplier audit management
  • Incoming inspection records
  • Component lot traceability
  • Supplier scorecards
Production Records
Device History Records (DHR)
  • Work order management
  • Batch/lot tracking
  • In-process inspections
  • Equipment calibration
  • Electronic batch records
QMS Core
Quality Management System
  • Document control (SOP/WI)
  • Training management
  • CAPA management
  • Nonconformance tracking
  • Audit management
Post-Market
Surveillance & Complaints
  • Complaint handling
  • MDR/MedWatch reporting
  • Field safety actions
  • Product recall management
  • Trend analysis

Built for Two Realities

Whether you're building compliance from scratch or untangling years of ad-hoc systems, HV|MedTech adapts to your situation.

Early Stage
Building Your First QMS

Startups and emerging companies preparing for their first FDA submission need systems that scale with them—not enterprise software they'll outgrow the implementation of.

  • Start with DHF, add modules as you scale
  • Built-in Section 524B compliance from day one
  • Templates based on FDA expectations
  • Investor-ready documentation
  • Scalable pricing that grows with you
Established
Remediating Disconnected Systems

Companies with products on the market often discover during audits that their systems don't connect. HV|MedTech provides the data infrastructure to unify what exists.

  • Connect existing data sources
  • Close audit findings systematically
  • Add SBOM compliance to legacy products
  • Unified complaint-to-CAPA traceability
  • Prepare for QMSR transition

35+ Years in Regulated Life Sciences

HV|MedTech is built by Richard Love, who has spent his career at the intersection of quality systems and manufacturing operations in FDA-regulated industries.

From biotech startups to GSK and Emergent BioSolutions, Richard has led quality organizations through FDA inspections, product launches, and the real-world challenges of maintaining compliance while shipping product.

This isn't consulting theory. It's hard-won experience distilled into systems that work.

Investment by Regulatory Stage

Pricing reflects the complexity of your regulatory requirements and data infrastructure needs.

Tier 1
Foundation
"Pre-submission startups"
$20K one-time
Includes
  • Design History File (DHF)
  • Basic document control
  • SBOM Management
  • Supplier Quality
Best For Pre-revenue companies preparing 510(k) or De Novo submissions
Tier 2
Compliance
"Ready for FDA scrutiny"
$45K one-time
Includes
  • Everything in Foundation
  • SBOM Management
  • Supplier Quality
  • QMS Core
Best For Companies with cleared devices entering production
Tier 3
Production
"Full manufacturing"
$70K one-time
Includes
  • Everything in Compliance
  • Production Records (DHR)
  • Post-Market Surveillance
  • Advanced analytics
Best For Companies with products on market and production volume
Tier 4
Enterprise
"Remediation & integration"
$90K+ scoped
Includes
  • All six applications
  • Legacy system integration
  • Custom compliance modules
  • AI-powered analytics
Best For Established companies remediating audit findings or integrating acquisitions

All tiers include implementation, training, and 90 days of support. Quickbase subscription billed separately.

Common Questions

The Quality Management System Regulation (QMSR) replaces the legacy QSR (21 CFR Part 820) and aligns FDA requirements with ISO 13485:2016. Effective February 2026, QMSR requires a process-based quality management system with risk-based thinking throughout. Key changes include explicit requirements for quality planning, resource management, and measurement analysis. HV|MedTech is designed around ISO 13485 structure, making your QMSR transition straightforward.
An SBOM is a comprehensive inventory of all software components in your medical device—including open-source libraries, third-party code, and version information. Under FDA's cybersecurity requirements (Section 524B), manufacturers must maintain current SBOMs, monitor for vulnerabilities in listed components, and demonstrate lifecycle security management. HV|MedTech's SBOM Management module tracks components, automates vulnerability monitoring, and generates FDA-ready documentation.
Enterprise platforms like Veeva, MasterControl, and ETQ are powerful but require 6-18 month implementations, dedicated IT resources, and six-figure annual commitments. HV|MedTech deploys in weeks at a fraction of the cost, running on Quickbase—a platform your team can configure and maintain without specialized IT staff. For growing medical device companies, you get FDA-ready infrastructure without enterprise complexity.
Absolutely. Many customers start with DHF during product development, then add SBOM and Supplier Quality as they approach clearance, and Production Records when they begin manufacturing. Each module is designed to integrate with the others, so adding capability is straightforward.
Quickbase provides the technical controls (audit trails, electronic signatures, access controls) that support Part 11 compliance. HV|MedTech applications are configured to leverage these controls appropriately. We also provide procedural guidance for maintaining compliance in your validated state.
Foundation tier typically deploys in 4-6 weeks. Compliance tier in 8-10 weeks. Production tier in 12-16 weeks. Enterprise implementations vary based on integration complexity and data migration requirements. These timelines assume reasonable customer availability for requirements and testing.

Ready to Build Your FDA-Ready Infrastructure?

Let's discuss your regulatory requirements and find the right approach for your company.