Healthcare Compliance Services

They cover the work of getting a product in line with the rules that apply to it: patient data protection under HIPAA or GDPR, and medical device rules under the FDA or the EU MDR once your software has a clinical purpose. A full healthcare compliance program runs from the initial assessment through the risk file and the technical controls to the evidence package behind them. Advisory services usually stop at the recommendation, and we carry on into the implementation, so the compliance experts who find a problem sit with the engineers who fix it.

Which compliance requirements apply depends on what the software does. If it stores or transmits protected health information in the US, HIPAA and HITECH apply, and anything touching EU residents brings in GDPR. If the software has a medical purpose, it becomes a device, and then you are looking at 21 CFR Part 820 under the QMSR and IEC 62304 for the software lifecycle, with ISO 14971 governing risk management throughout.

Selling in Europe adds the EU MDR. Enterprise buyers usually ask for SOC 2 Type II or HITRUST as well, though neither is a legal requirement, and both tend to show up in procurement long before a contract does.

Medical device compliance is the narrower of the two. It covers what a regulated device and its software have to satisfy: a quality system under ISO 13485 and a software lifecycle under IEC 62304, with a risk file kept current to ISO 14971. The wider category takes in data privacy and reimbursement rules, plus obligations that reach organizations across the healthcare industry when no device is involved. Plenty of products sit in both, so we scope the regulatory and compliance work as one program rather than two.

Start with classification, because the class decides your pathway and the evidence you have to produce. After that the work splits in two: a quality system that meets Part 820 as it now stands under the QMSR, and design and development controls that maintain traceability between applicable user needs, design inputs, outputs, risk controls and verification and validation evidence.

Software adds IEC 62304 documentation at whatever safety class your hazard analysis lands on, and a connected device adds a cybersecurity plan with a software bill of materials under Section 524B. Miss those and the submission can be refused before anyone reads the clinical content. The submission itself is mostly an assembly job, which is far easier when the evidence was produced as the product was built.

HIPAA applies to covered entities such as providers and health plans, and to the business associates handling protected health information for them. Most health tech vendors are business associates, which means the Security Rule lands on you directly and a signed business associate agreement becomes a condition of doing business.

For a software team, healthcare software compliance comes down to access control, audit logging, encryption in transit and at rest, and a risk analysis you can produce on request. Policies and procedures are part of it, though the Security Rule also expects technical controls that enforce them. The risk analysis is what catches people out, because it has to describe the system as it runs today.

No, and it is worth being clear about that. Certificates come from a notified body or an accredited auditor, and clearance to market comes from the FDA. What we can do is prepare the submission so it holds together, and make sure the product behind it behaves the way the documentation says. Our own ISO 13485 certification helps you in a practical way here, since your project runs inside a quality system that has already been certified.

For a product already on the market with a codebase in reasonable shape, a privacy or SOC 2 readiness program usually runs three to six months, and most of that is engineering rather than writing. A first FDA submission for Class II software is a longer road, commonly nine to eighteen months from a standing start. What moves the number is how much of the architecture has to change to support the controls, so we give you a date after the assessment rather than before it.

Post-market obligations never really stop. You have to watch every component in your software bill of materials for newly disclosed flaws and patch the ones that matter, then report events that cross the reporting threshold in each market you sell into.

All of that depends on patching being safe, so we set the update path up properly: signed images on A/B partitions, with a health check before the switch and a rollback tested on production hardware. Signing keys live in a hardware root of trust rather than a config file. Surveillance data then goes back into the risk file, which keeps your documentation current instead of frozen on the date of approval.

Yes, and that is usually why teams call us. Our medical device compliance consulting services sit in the same company as the engineers who write the firmware and build the cloud platform behind it, so a finding turns into a ticket rather than a report someone has to translate for a separate development vendor.

You can also take a single piece. Some teams bring us in for the assessment and nothing else, others for the IEC 62304 documentation on software that already exists, and we customize the scope from there.

Early on, most funded teams outsource it. A fractional compliance officer gives you compliance expertise that has already been through submissions and inspections without the cost of a senior full-time hire, and that usually carries you through the quality system setup and a first submission. The moment to bring it in-house tends to arrive once the product is on the market and post-market surveillance becomes a standing job for an internal compliance team, and we often hand over at that point and stay on for the engineering.

It follows the shape of the engagement. A gap analysis is a fixed scope that lands in weeks, while a remediation program is priced by the team it takes and how long the runway is. As a nearshore partner, our blended rate sits well below what large advisory firms charge, and a much bigger share of the budget goes into implementation instead of reporting, which makes a full remediation program more cost-effective than an advisory engagement of the same size. We put a number on it once that is done, since it depends on how much evidence already exists.