How we can help
Find your situation — we have the right approach.
You have a product idea — but no regulated software team.
Maybe you're building a patient-facing app, a clinical decision support tool, an AI-powered analysis pipeline, or a connected device that needs a certified software layer. You know what it should do — but getting it through IEC 62304 and past a notified body isn't your core competency.
This is where most of our engagements start. We don't just write code — we build the full regulatory and technical foundation so you're not retrofitting compliance six months in.
What we do
- Regulatory strategy — which classification, which pathway, which standards apply
- System architecture designed for IEC 62304 compliance from the start
- Full-stack development (mobile, cloud, embedded) under a controlled process
- Risk management per ISO 14971, integrated into development — not a separate workstream
- Technical documentation that's written to convince a notified body, not just to check a box
- UX design that meets both usability standards (IEC 62366) and real user needs
What you get
A certified, market-ready product — and the documentation package to prove it.
Your product is on the market. Now you want to add software.
You already have a certified device or IVD product with an established QMS. You're thinking about a companion app, an AI-powered evaluation tool, cloud connectivity, or digital reporting. The challenge isn't starting from zero — it's making new software fit into the regulatory framework you've already built without breaking anything.
We meet you where you are. We don't impose our process — we integrate into yours.
What we do
- Review your existing regulatory architecture and QMS maturity
- MDR/IVDR compliance evaluation for the planned software addition
- SOUP risk assessment and management
- Development that's integrated into your existing QMS workflows
- Documentation that matches your current structure and terminology
- Support through notified body submission and Q&A rounds
What you get
Software that fits your regulatory maturity level — not a parallel universe of documentation that contradicts what you already have.
You're building — and want to make sure your documentation and processes are audit-ready.
You have a development team and a product taking shape — but the IEC 62304 documentation and ISO 14971 risk management aren't running as structured as they should be. Maybe the process isn't end-to-end, or maybe documents have been written that wouldn't hold up in front of a notified body.
We bring structure without slowing down your development. The goal: documentation and processes that fit your product from the start — not bolted on after the fact.
What we do
- Current-state analysis — what's there, what's missing, what needs rework
- Process alignment to IEC 62304 and ISO 14971
- Documentation remediation and gap-closing
- Preparation for audits, including dry runs and Q&A coaching
What you get
Documentation and processes that fit your product and hold up in front of a notified body.
Your product is certified. Now you need ongoing support.
Your product is on the market — but regulated software isn't fire-and-forget. Every change, whether a bug fix, new feature, or updated dependency, must be assessed, documented, and verified. Add post-market surveillance, vigilance requirements, and evolving QMS expectations.
We handle the ongoing change management and regulatory maintenance so your team can focus on product development.
What we do
- Change impact analysis and risk reassessment with every release
- Verification and documentation updates for software changes
- SOUP monitoring and vulnerability assessment
- Post-market surveillance (PMS) and PSUR support
- QMS evolution and process optimization
What you get
A continuously maintained, regulatorily current product — without your team having to become documentation experts.
You want an experienced second opinion before you submit.
You're building software in-house or with another development partner. Things are moving, but you have a nagging feeling about your architecture, your risk file, or your technical documentation. You'd like someone with deep SaMD experience to review what you have — honestly and independently.
This is a low-commitment engagement. No multi-month contracts, no takeover. Just a focused review with clear findings.
What we do
- Architecture review against IEC 62304 expectations
- Risk file review (ISO 14971 / ISO 24971)
- Technical documentation spot-check
- Honest assessment with prioritized recommendations
What you get
Clarity on where you stand — and a concrete list of what to fix before submission.
We're small on purpose.
We could scale. We choose not to — because in regulated software, knowledge continuity matters more than headcount. When you work with Liftric, you work with senior engineers who've been in regulated medical software for over a decade. Not juniors learning on your project. That also means we're selective about what we take on. If we say yes, we're fully committed. If we think someone else is a better fit, we'll tell you.
Same people throughout
The people you talk to in the first meeting are the people who build your product.
SLA-based lifecycle support
Every project comes with SLA-based lifecycle support — we don't disappear after launch.
Documentation as portability
Our documentation is thorough enough that you could switch partners tomorrow and not lose a thing (though we'd prefer you didn't).
Have questions about how we work, pricing, or the process? See frequently asked questions →
Book a free introductory call — we'll discuss your project and outline actionable next steps.
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