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
The result
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 and integrate into your process instead of imposing ours.
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
The result
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
The result
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
The result
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
The result
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.
Book a meeting
