MDSAP & HIPAA Compliance Consulting
Navigate the most demanding healthcare compliance programs — MDSAP for medical device manufacturers, HIPAA for organizations handling protected health information.
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Two high-stakes healthcare compliance programs, one experienced team
MDSAP (Medical Device Single Audit Program) is a program that allows a single regulatory audit to satisfy the requirements of multiple regulatory jurisdictions — including the FDA (US), Health Canada, ANVISA (Brazil), TGA (Australia), and MHLW/PMDA (Japan). Adopted by Health Canada in 2019 as the only accepted audit mechanism, MDSAP is increasingly the global standard for medical device quality system oversight.
HIPAA (Health Insurance Portability and Accountability Act) requires covered entities and business associates to protect the privacy and security of electronic protected health information (ePHI). Non-compliance carries civil and criminal penalties — and enforcement is increasing.
Who needs MDSAP & HIPAA consulting?
Medical device manufacturers (MDSAP)
- Selling into Canada — MDSAP is mandatory since 2019
- Exporting to Japan, Brazil, or Australia and needing a single audit pathway
- Seeking FDA recognition as an alternative to 21 CFR 820 inspections
Healthcare organizations (HIPAA)
- Covered entities: hospitals, clinics, health plans, clearing houses
- Business associates: IT vendors, billing companies, cloud storage providers handling ePHI
- Organizations after a breach or OCR investigation
Overlapping regulated environments
- Medical device companies that also handle patient data
- Health tech companies building software as a medical device (SaMD)
- Organizations integrating ISO 13485 with MDSAP requirements
Our approach
Regulatory compliance built into operations — not layered on top after the fact.
- 1
Regulatory gap assessment
We assess your current QMS or information security program against MDSAP grading criteria or the HIPAA Security & Privacy Rules.
- 2
Remediation planning
Prioritized action plan addressing procedural, technical, and administrative gaps — mapped to regulatory citations.
- 3
Documentation & implementation
We co-build or update required documentation: SOPs, risk assessments, breach notification procedures, Business Associate Agreements, and more.
- 4
Mock audit & readiness review
Internal simulation of an MDSAP audit or HIPAA compliance review before the real thing — findings closed before the auditor arrives.
What you get
Regulatory gap report
Findings mapped to MDSAP audit criteria or HIPAA rule citations — with severity ratings and remediation owners.
Updated QMS documentation
Procedures, work instructions, and records aligned to MDSAP process categories or HIPAA administrative safeguards.
Risk assessments
MDSAP-required risk management documentation or HIPAA-required Security Risk Analysis (SRA) — audit-ready.
Mock audit report
Internal assessment findings, graded findings (for MDSAP), and evidence review before your actual regulatory audit.
CAPA management
Open finding tracking through closure, with verified objective evidence — no finding left open at audit time.
Ongoing compliance support
Annual HIPAA review or MDSAP surveillance readiness program to keep your compliance current as regulations evolve.
Related services
GMP / ISO 13485
Medical device quality management system certification — the foundation most MDSAP programs build on.
Learn moreRCA / CAPA for FDA
Root cause analysis and corrective action programs that satisfy FDA and MDSAP requirements.
Learn moreISO 27001
Information security management that provides a structured framework for HIPAA Security Rule compliance.
Learn moreReady to tackle your regulatory compliance?
The first conversation is always free. We’ll scope the work, give you a realistic timeline, and tell you whether we’re the right fit.
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