CONDUCTING A COMPLIANCE DISCOVERY FOR A MEDTECH COMPANY

Find out how DBB Software helped a medtech company prepare for HIPAA and GDPR certification.

Industry

Healthcare & Biotech

Service

Product Discovery

Team

2 Tech Leads (Part-Time)

Project State

December 2024 - February 2025

Country

United States

About the Client

Biolux Technology is a U.S.-based medical device company focused on improving oral health through advanced light-accelerated orthodontic systems. Their innovative solutions combine hardware, software, and data insights to enhance patient outcomes and treatment efficiency for dental professionals worldwide.

THE CLIENT'S  INITIAL REQUEST

The client reached out to DBB Software because its customers required official confirmation that all patient data was stored and processed securely:

Compliance Readiness Assessment

Evaluate Biolux’s existing systems and define what changes are necessary to achieve HIPAA and GDPR compliance.

Security and Infrastructure Review

Analyze AWS cloud configuration and data-handling processes to identify risks and vulnerabilities.

Partner Selection for Compliance Audits

Find reliable third-party partners to perform official HIPAA and GDPR assessments.

Risk Documentation and Mitigation Plan

Deliver a detailed discovery report summarizing system gaps and step-by-step remediation recommendations.

SOLUTIONS WE DELIVERED

DBB Software led a focused two-month compliance discovery phase, assessing the client’s infrastructure, identifying risks, and preparing a full roadmap toward HIPAA & GDPR certification:

Infrastructure & Security Analysis

Performed a thorough review of AWS setup, including IAM roles, VPC configuration, data encryption, logging, backups, and access policies.

Risk Documentation & Remediation Plan

Delivered a detailed discovery report outlining platform risks, misconfigurations, recommended fixes, and long-term compliance strategies.

Compliance Partner Sourcing

Assisted the client with finding technical auditors to provide an official HIPAA/GDPR infrastructure assessment and training, and certification providers to onboard employees into HIPAA-compliant workflows and ensure internal security awareness.

Strategic Guidance for Certification

Provided consulting support on privacy policies, data-access flows, audit requirements, workforce management, and best practices for PHI handling across administrative tools and patient-doctor communication modules.

RESULTS ACHIEVED

Compliance Readiness Roadmap

Delivered a full set of documentation and risk assessments to prepare Biolux for HIPAA and GDPR certification.

Improved Infrastructure Awareness

Identified and addressed potential AWS configuration vulnerabilities.

Strategic Partner Alignment

Connected the client with qualified compliance auditors to accelerate the next phase of certification.

Get a Complete Product Assessment

Receive a complete assessment of your solution and a ready-to-use roadmap with a Scope Doc.

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