Healthcare Compliance Services
Your trusted compliance partner for every stage of growth – helping you meet regulations, avoid risk, and move forward with clarity and control.
Our HealthcareCompliance Services
HIPAA compliant software development
We build software with HIPAA compliance baked in. From secure architecture to encrypted data flow, we make sure your product protects patient privacy. With our healthcare compliance services, you’ll launch with confidence, knowing your software meets healthcare standards.
Compliance audit & consulting
SPsoft experts audit your systems, policies, and workflows to uncover gaps in HIPAA, FDA, GDPR and help you close them fast. Whether you’re launching a new product or tightening existing processes, we make compliance feel doable (and even a little empowering).
QMS setup and management
A solid QMS is your foundation of safe, compliant, and audit-ready healthcare products. We help you set it up right: documented, streamlined, and aligned with ISO 13485, FDA, and your actual workflows. Whether you’re a startup or scaling, we’ll tailor it to your team, tools, and growth goals.
Software verification and validation (V&V)
SPsoft team handles the full verification and validation (V&V) process to make sure your healthcare software is tested, documented, and ready for regulators. Our team works closely with yours to create clear, compliant test cases and traceability.
FDA-compliant technical documentation
We write and organize everything from Design History Files (DHF) to risk analyses and traceability matrices – all aligned with FDA expectations. Our team speaks both tech and regulatory, so you don’t get lost in the jargon. Get the docs that smooth the whole approval process.
Data privacy & security compliance
SPsoft helps you align with HIPAA, GDPR, and global data privacy laws through secure architecture, access controls, and strong encryption. Beyond technical setup, we guide you on policies, breach response, and staff training. It’s the full picture of data security built into your software and culture.
Get Expert Help With Your Cloud Compliance Journey
Let’s plan your cloud strategy with HIPAA, security, and scalability in mind.
What You Get by Partnering with SPsoft
A strategic partner who plans a few steps ahead
We align with your long-term goals to build smart, future-proof roadmaps that focus on what drives your business forward.
Tech solutions crafted with deep domain expertise
Our team includes practicing clinicians and health professionals who design systems that both perform well and meet strict industry regulations.
Seamless integration by default
We build our healthcare compliance services with interoperability in mind, making sure our work fits right into your EMR and EHR systems through FHIR, HL7, and other industry protocols your team already uses.
Cutting-edge AI, real results
We leverage advanced technologies to help you achieve better outcomes faster with less time and budget.
A boutique approach with big impact
We work with a select number of partners to deliver highly customized, AI-driven healthcare solutions that truly make a difference.
Our Other Healthcare Software Services
Custom Software Development
Get your unique telehealth, EHR/EMR systems with AI capabilities, and practice management software in modern UI. Use our expertise in SaMD-compliant development, medical imaging DICOM, or latest AI best practices.
Interoperability solutions
Leverage our expertise in cross-platform healthcare data interoperability, FHIR/HL7 integrations with Epic and other EHRs, SMART on FHIR app development, healthcare data analytics on FHIR, and seamless data conversion to FHIR.
Cloud services
We support healthcare organizations with cloud infrastructure security audits, optimization, automation, and maintenance. We will help you migrate heavy legacy software to the cloud.
Healthcare AI solutions
We build AI-boosted healthcare products from scratch, empowering your existing software with AI capabilities, augmenting your internal AI experts team, and more.
FAQ About Healthcare Compliance Services
What are healthcare compliance services, and why do we need them?
Healthcare compliance services help ensure your software, systems, and operations meet strict industry regulations like HIPAA, FDA, and GDPR. These services cover everything from audits and documentation to secure architecture and regulatory filings. Without proper compliance, you risk fines, delays, security breaches, and even blocked access to the market. It’s not just about checking boxes – it’s about protecting patients, building trust, and moving forward safely. If you’re in healthcare tech, compliance is mission-critical.
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What’s the difference between HIPAA, GDPR, and FDA compliance?
HIPAA protects patient data privacy in the U.S., GDPR governs personal data across the EU, and FDA compliance is about the safety and regulation of software that acts as a medical device (SaMD). HIPAA focuses on how health data is stored, shared, and secured. GDPR is broader and applies to all personal data, with strict consent and data access rules. FDA compliance involves clinical safety, software validation, and approval processes. Depending on your product and geography, you may need to meet one, two, or all three.
Do startups need to be fully compliant before launch?
Not always — but it’s critical to understand what’s required early and have a clear compliance plan. Some regulations, like HIPAA, should be addressed upfront, especially if you’re handling patient data or partnering with healthcare providers. Others, like FDA approval, may only apply once your product reaches a certain feature set or enters the market. That’s why it’s smart to build with compliance in mind from the beginning — it’s much harder to retrofit later.
Think of it as scaling compliance responsibly over time, not all at once. Want to talk through your roadmap? Let’s discuss our healthcare compliance services.
Who is responsible for ensuring our software is compliant?
Ultimately, it’s your company’s responsibility, whether you’re a startup or an enterprise. That said, a good compliance partner (like us!) works closely with your product, engineering, and legal teams to guide you through every step. Compliance isn’t just a legal checkbox – it’s part of your tech stack, your documentation, and your day-to-day operations. We help you build a culture and process that makes staying compliant a lot easier. So yes, it’s your responsibility, but you don’t have to go it alone — we’re here to help.
In your healthcare compliance services, do you offer verification and validation (V&V) services for our software?
Yes! We handle full verification and validation (V&V) processes to make sure your software does exactly what it’s supposed to do: safely and reliably. That includes developing and executing test cases, building traceability matrices, and aligning everything with FDA or ISO requirements. Whether you’re launching a SaMD or just tightening quality controls, we’ve got you covered. V&V isn’t just about passing audits – it’s about building confidence in your product.
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Can you set up our QMS (Quality Management System) from scratch?
Absolutely. We help you set up a QMS aligned with ISO 13485, FDA, and your internal quality standards without overwhelming your team. It’s fully tailored to your product stage, team size, and regulatory needs. From SOPs to risk management to documentation workflows, we build systems that are both audit-ready and easy to manage. A great QMS gives you structure, clarity, and way less stress when scaling.
How much do healthcare compliance services cost?
Healthcare compliance services costs depend on the complexity of your product, the regulations you’re working under, and how much support you need. A startup might spend a few thousand for audits or templates, while a full FDA-ready compliance program can run into five or six figures. We offer flexible, scalable payment options. Think of it as an investment in speed, safety, and avoiding costly mistakes. We’ll work with you to find a smart, cost-effective path.
How long does it take to become compliant?
It depends on what type of compliance you’re aiming for. A basic HIPAA setup might take a few weeks, while FDA SaMD approval or ISO QMS certification can take months. The timeline also depends on your current readiness: are you starting from scratch or already halfway there? We’ll assess where you are and create a roadmap that fits your goals.
Can we get compliant in phases or do it all at once?
Yes, and in most cases, phased compliance is the smartest approach. We help you prioritize what’s urgent (like HIPAA if you’re handling PHI) and then build out the rest over time. This keeps costs manageable and aligns with your product roadmap. Compliance shouldn’t block your progress – it should grow with you. Think of it as building a solid foundation, one step at a time.
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What parts of compliance can we automate?
Quite a few! You can automate access controls, data encryption, audit logs, policy reminders, vulnerability scanning, and even parts of your QMS. We help you integrate tools that reduce human error and make compliance easier to maintain day to day. Healthcare compliance services with automation won’t replace the need for good processes, but it definitely help scale them. The key is using the right tools for your workflow and regulatory needs. Work smarter, stay safer.