Medical Device Engineering Services

We do both. Our medical device engineering services cover the full stack, from PCB design and enclosure engineering to firmware, embedded software, and cloud platforms. This range of services means one team handles hardware and software together, so nothing gets lost in handoffs between vendors.

That’s what we do! We offer medical device software engineering for SaMD products, from risk analysis and UI design to cloud connectivity and compliance.

We operate under an ISO 13485-certified quality management system and are also ISO 9001 and ISO/IEC 27001 certified. On projects, we design and document devices to FDA 21 CFR 820 (QMSR), EU MDR and IVDR, ISO 14971 for risk management, IEC 62304 for software lifecycle, IEC 62366-1 for usability, IEC 60601-1 and IEC 60601-1-2 for electrical safety and EMC, and IEC 81001-5-1 plus FDA premarket cybersecurity requirements for connected devices.

We engineer the whole device except serial production: hardware, firmware, software and cloud, plus the documentation that proves they are safe. You can engage us for the full device or for a single layer:

• Hardware: industrial design and enclosure, electronics and PCB design, component selection, prototypes, hardware documentation
• Firmware: embedded software in Rust and C/C++, BSP and drivers, RTOS, BLE/Wi-Fi connectivity, secure boot and OTA updates
• Software: companion mobile apps, SaMD modules, patient and clinician interfaces
• Cloud and integrations: device-to-cloud platforms, fleet management, HL7/FHIR integration with EHRs
• AI: on-device (TinyML) and cloud algorithms, validation, PCCP
• Manufacturing: design for manufacturing, design transfer to your contract manufacturer, pilot runs

We don’t do serial production (your contract manufacturer does), formal certification testing (accredited labs do), and we don’t act as the legal manufacturer of the device.

Everything we produce becomes your property and goes into your design history file and technical documentation. A typical handover for a Class II device includes:

• Design and requirements: user needs, system and software requirements, architecture and detailed design, traceability matrix (requirements ↔ risks ↔ tests)
• Hardware: schematics, PCB layout and Gerber files, BOM with approved alternates, mechanical CAD and drawings
• Firmware and software: source code and build instructions, IEC 62304 documentation set (development plan, safety classification, verification records, release notes), SOUP list, SBOM
• Risk and usability: ISO 14971 risk management file, IEC 62366-1 usability engineering file
• Cybersecurity: threat model, security risk assessment, penetration test report, vulnerability management plan
• Verification and validation: test protocols and reports, pre-compliance test results
• Manufacturing: design transfer package, end-of-line test specifications, DFM report
• Regulatory: draft sections for your 510(k), De Novo or PMA submission (eSTAR), or EU MDR/IVDR technical documentation

Documents follow your eQMS templates, or ours if you don’t have them yet.

Our QMS is certified to ISO 13485 for. It governs how we design and develop your device:

• design and development planning, inputs, outputs, reviews, verification, validation, transfer and changes
• risk management (ISO 14971) and software lifecycle processes (IEC 62304)
• document and record control, configuration management
• control of suppliers and subcontractors (components, PCB assembly, test labs)
• engineer training and competence, internal audits, corrective and preventive actions (CAPA)

Our QMS does not replace yours. As the legal manufacturer, you need your own QMS for production, labeling, complaint handling, post-market surveillance and vigilance. We work as your certified design supplier under a quality agreement, either within our QMS or inside your procedures. Project data is protected under our ISO/IEC 27001-certified information security management system.

As the manufacturer, you carry legal responsibility for the device. Each of the other parties covers one part of the work:

• Manufacturer (you): intended use and claims, final classification, your own QMS, Declaration of Conformity, submissions to the FDA or a Notified Body, registration (FDA listing, EUDAMED), person responsible for regulatory compliance (PRRC, EU), clinical evaluation, labeling, post-market surveillance and vigilance.
• Yalantis: engineering of the device and the evidence you sign and submit: design documentation, risk and usability files, verification and validation, cybersecurity documentation and submission inputs. We answer technical questions and deficiency letters together with you.
• Regulatory consultant: regulatory strategy sign-off, pathway and predicate selection, FDA Pre-Submission meetings, clinical evaluation report, submission compilation, and US Agent or EU Authorized Representative if you’re based outside that market. Our regulatory specialists can cover strategy and documentation or work alongside your consultant. [CONFIRM what’s in-house]
• Accredited test lab: formal testing and reports for electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), radio (FCC, RED), biocompatibility and IP rating, plus CB test reports. We write the test plan, run pre-compliance tests, support the lab and fix findings.
• Certification body or regulator: in the EU, a Notified Body audits your QMS and technical documentation and issues the CE certificate. In the US, the FDA reviews the device and clears or approves it. In the UK, a UK Approved Body handles UKCA. MDSAP audits are run by MDSAP auditing organizations. None of these bodies consult or design.

Yes. We provide software design for medical devices in line with FDA and MDR regulations, as well as ISO 13485 and IEC 62304 standards, to support smooth approvals and safe releases. That applies to software development for medical devices as well.

Yes. We prepare technical documentation per EU MDR 2017/745, support Notified Body audits, and help with CE marking for European market access. We also handle multi-market strategies through MDSAP, which covers the US, Canada, Brazil, Australia, and Japan.

Class II covers moderate-risk devices like infusion pumps and powered wheelchairs. Class III is for high-risk products such as implantable pacemakers. For Class II, we typically follow the 510(k) pathway with a 12 to 24 month timeline. Class III requires PMA approval with clinical evidence, and usually takes 3 to 7 years. Our design controls and testing scale with the regulatory requirements of each class.

For most Class II devices going through the 510(k) pathway, you can expect 12 to 24 months from concept to clearance. Class III devices that need PMA approval typically take 3 to 7 years because of clinical trial requirements and longer FDA review cycles. We work to shorten those timelines by running hardware and software development in parallel and starting documentation early.

The biggest factors are device class, regulatory pathway, and how much groundwork is already in place. Class II devices with a clear 510(k) predicate generally move faster and cost less, while Class III products requiring PMA take significantly longer and carry higher costs because of clinical trials and extended review cycles. We shorten development timelines by running hardware, firmware, and software in parallel and starting regulatory documentation from the first sprint. Since every project is different, the best way to get a realistic estimate is to talk to our team about your specific device and regulatory situation.

Challenges in medical device software development often originate from poor vendor documentation or integrating multiple devices. We handle this by working with vendors directly or suggesting better-documented alternatives. For multi-device setups, we merge and normalize data to ensure smooth processing. Every project is unique, so issues may vary.

We can. Yalantis is a medical device design firm that also delivers medical device interoperability services, supporting integration with EHRs, hospital platforms, and HL7/FHIR standards.

We develop medical device software solutions that standardize and synchronize data across various devices, so the data exchange is smooth and compliant.

Yes, we do it as part of our medical device software development services. We conduct strict verification and validation (V&V) testing to ensure software safety, reliability, and compliance.

We’ve delivered medical device engineering services for all classes of FDA-approved devices and built custom medical device solutions from scratch. Our team develops medical device software for diagnostics, remote monitoring, and chronic disease management, and we offer consulting and ongoing outsourcing when needed. This makes us a long-term partner for healthcare companies that require seamless data integration and dependable outcomes.