Medical device software development

Expedite compliant medical device software development with Innowise. ISO 13485-certified, we shorten development journeys while ensuring your SaMD and SiMD solutions meet all applicable FDA, MDR, HIPAA, GDPR, and ISO/IEC requirements.

60+

in-house medical software developers

60+

in-house medical software developers

ISO 13485

ISO 9001, ISO 27001, ISO 27017, and ISO 27018 certified

Compliant

with FDA, MDR, HIPAA, GDPR, HITECH, IEC 62304, and others

Expertis

in HL7, FHIR, XDS/XDS-I, DICOM, and other healthcare standards

Vårdföretag som vi betjänar

Each healthcare business is different and has different needs when it comes to medical device software development services. With over 18 years of experience as a medical software development company, we have learned to tailor our solutions to the business needs so our clients get exactly what they need.

Medical technology companies

Device manufacturers
Software companies
Nystartade företag inom MedTech

Streamlined regulatory clearance
Faster market entry
Competitive edge thanks to advanced tech

Vårdgivare

Hospital systems
Research centers
Laboratories
Apotek

Optimized clinical workflows
Förbättrad diagnostisk precision
Seamless integration with IT systems
Secure patient data management

Life sciences organizations

Läkemedelsföretag
Forskningsinstitut
Clinical trial centers

Accelerated research cycles
Evidence-based analytics
Förbättrad dataintegritet
Compliant documentation for regulatory submissions

Health technology innovators

Medical education platformsv
Healthcare NGOs
Digital health ventures

Concept-to-product transformation
Pitch decks, prototypes, and documentation for seed and pre-seed rounds
Scalable architecture and reliable frameworks
Access to specialized niche medical IT expertise

Standards our quality management rests on

Kvalitetshantering

ISO 13485

Medical devices. Quality management systems: requirements for regulatory purposes

Development life cycle

IEC 62304

Medical device software. Software life cycle processes

Riskhantering

ISO 14971

Medical devices. Application of risk management to medical devices

Usability engineering

IEC 62366

Medical devices. Application of usability engineering to medical devices

Need a reliable medical software development firm?

Innowise can do it all — build SaMD and SiMD while navigating compliance needs.

Types of medical device software

Standalone software that performs medical functions without being a part of hardware medical devices.

Regulatory oversight

US (FDA): Class I, II, or III based on SaMD risk level
EU (MDR): Class I, IIa, IIb, or III based on Rule 11 and other applicable rules

Target devices SaMD operates on

Consumer electronics: smartphones or tablets
Computing devices: PCs, laptops, or edge-computing devices
Connected devices: smartwatches, wearables, or fitness trackers
Smart home systems: TVs, smart speakers, and other IoT devices

Real-life SaMD examples

Medical image analysis app detecting radiological abnormalities (US II/EU IIb)
Chronic disease management app delivering CBT for depression management (US II/EU IIa)
Remote patient monitoring solution tracking vitals, analyzing them, and sending alerts (US II/EU IIa)
Clinical decision support tool analyzing patient data and suggesting treatment protocols (US II/EU IIb)

Embedded software that controls medical device operation, processes device data, or enables the hardware to perform the device’s medical purpose.

Regulatory oversight

US (FDA): SiMD is regulated according to the classification of the parent medical device (Class I, II, or III)
EU (MDR): SiMD is regulated as part of the device under applicable MDR rules

Target devices for SiMD

Class I devices (low-risk): basic ward monitoring interfaces, in-built medical device data systems (MDDS), etc.
Class II devices (medium-risk): infusion pump controllers, diagnostic imaging systems, non-invasive ventilators, etc.
Class III devices (high-risk): implantable cardiac devices, brain-computer interfaces, automated drug delivery systems, etc.

Real-life SiMD examples

Cardiac rhythm management software for implantable pacemakers that detects arrhythmias (US III/EU III)
Medical image processing system for MRI machine that turns raw scan data into diagnostic quality images (US II/EU IIb)
Lung ventilation algorithms for ICU ventilators to control respiratory support parameters (US II/EU IIb)
Closed-loop glucose control software calculating and administering insulin doses (US III/EU III)

Sample medical device software we build and implement

Whether you want to launch a decision-supporting SaMD product or a medical device as a service, Innowise has your back. With medical software development services spanning various categories, we are ready to deliver SaMD and SiMD solutions tailored to your needs and medical specialty.

Disease diagnostics and treatment planning

Medical imaging

Disease management and monitoring

Disease diagnostics and treatment planning

Clinical decision support software (CDSS) providing AI diagnostic insights and treatment recommendations
Personalized medicine solutions performing genomic analysis and generating data-driven treatment plans
Seizure detection based on EEG recording analysis
AI-based arrhythmia detection using wearable ECG patches and holter monitors

Medical imaging

AI-assisted image analysis of ultrasound, MRI, CT, and X-ray scans to detect abnormalities
DICOM viewers for diagnostic images
Medical image enhancement solutions
Real-time video and image processing tools that provide physicians with additional information, e.g., quantification of organ’s sonographic characteristics

Disease management and monitoring

Closed-loop glucose monitoring and automated insulin delivery solutions
Blood pressure monitoring apps
Apps for smart inhalers enabling medication dosage tracking and treatment reminders
Sleep apnea episode detection and notification apps
ICU real-time vitals tracking and cloud-based analytics
Apps for heart rate, SpO2, and body temperature tracking with AI-driven insights

Disease diagnostics and treatment planning

Clinical decision support software (CDSS) providing AI diagnostic insights and treatment recommendations
Personalized medicine solutions performing genomic analysis and generating data-driven treatment plans
Seizure detection based on EEG recording analysis
AI-based arrhythmia detection using wearable ECG patches and holter monitors
AI-chattbot för patientförfrågningar

Medical imaging

AI-assisted image analysis of ultrasound, MRI, CT, and X-ray scans to detect abnormalities
DICOM viewers for diagnostic images
Medical image enhancement solutions
Real-time video and image processing tools that provide physicians with additional information, e.g., quantification of organ’s sonographic characteristics
Rekommendationer baserade på spårningsdata

Disease management and monitoring

Closed-loop glucose monitoring and automated insulin delivery solutions
Blood pressure monitoring apps
Apps for smart inhalers enabling medication dosage tracking and treatment reminders
Sleep apnea episode detection and notification apps
ICU real-time vitals tracking and cloud-based analytics
Apps for heart rate, SpO2, and body temperature tracking with AI-driven insights

Ready to take your medical device software idea from paper to reality?

Utmaningar som vi löser

Regulatory complexities

Being a mature medical software development company, we know how to navigate the major industry regulations and plan around compliance from day one.

Classification uncertainty

The line between regulated and non-regulated software may be blurry. We help our clients analyze software ideas, risks and accurately define the FDA/MDR class.

Technical documentation burden

Som en del av vår tjänster för utveckling av medicinsk programvara, we create compliant documentation with FDA/MDR requirements in mind so you get submission-ready files.

Delays due to validation

Besides running tests in parallel with medical software development services, we use risk-based validation frameworks to maintain compliance without delays.

Integration conflicts

Connecting medical software with existing clinical systems may be tricky, so we plan the integrations at the early stages and ensure seamless interoperability.

Complex adoption of advanced techs

Our wide range of in-house experts makes the adoption of AI, ML, big data, etc. smooth, handling both implementation and regulatory concerns around these techs.

Vår efterlevnad

Compliance is built into every step of our medical software development services. With hands-on experience and a dedicated team, we align your solution with FDA, MDR, ISO 13485, IEC 62304, IEC 82304-1, IEC 62366, and ISO 14971 and provide all the documentation for smooth regulatory clearance.

Our medical device software success stories

Benefits of our medical device software development services

01/04

Förbättrad patientvård

Our SaMD and SiMD solutions enable real-time decision support for healthcare professionals and smooth remote care for patients with chronic conditions. Leveraging technologies like AI, ML, dataanalys, our custom software supports personalized treatments, reduces diagnostic errors, and improves patients’ quality of lives.

02/04

Bättre operativ effektivitet

Smart medical device software we build streamlines even more complex clinical workflows: it takes over the analysis of patients’ health records and vitals and assists in diagnostics, care planning, and treatment delivery. As a result, doctors, radiologists, and lab specialists work faster, all while maintaining or exceeding the quality metrics.

03/04

Regelefterlevnad

With deep expertise in FDA, MDR, ISO 13485, and IEC 62304 standards, we make sure software stays compliant every step of the way. When partnering with Innowise, you get audit-ready documentation, proven quality management processes, and peace of mind knowing your SaMD or SiMD project is in the right hands.

04/04

Gained competitive edge

We know for sure that introducing innovative medical products makes healthcare businesses stand out among competitors — we’ve seen it happen for our clients. Whether you’re pioneering a new diagnostic device or expanding your digital health offering with a cutting-edge solution, we’ll help you stay ahead in a fast-paced healthcare market.

Förbättrad patientvård

Bättre operativ effektivitet

Regelefterlevnad

Gained competitive edge

Let’s turn your SaMD/SiMD project into reality

An ISO 13485-certified medical software development company, we’re here to help you.

Medical device software development roadmap for SaMD and SiMD

Here is a sample roadmap to develop compliant SaMD or SiMD software worry-free. Innowise’s team is ready to assist you at all the project stages and ensure your project is a success.

Outlining SaMD/SiMD product vision, intended use, and the clinical need it addresses
Analyzing the market landscape to shape the competitive edge of the product
Assessing initial project risks and technical feasibility of the medical device software
Defining the regulatory category (SaMD or SiMD) and preliminary class of the device according to FDA or MDR
Creating a high-level project and resource allocation plan

Gathering and documenting clinical, functional, and technical requirements for the future SaMD/SiMD solution
Defining user personas and software usage scenarios
Developing a regulatory strategy and compliance roadmap in line with all applicable regulations
Creation of a verification and validation (V&V) master plan
Aligning the development plan with the ISO 13485, ISO 9001, and IEC 62304 requirements to quality management

Creating detailed feature lists for each user role based on software requirements
Designing a flexible and resilient application architecture
Outlining a software security framework and data protection measures in line with HIPAA, GDPR, ISO 27001, and other requirements
Planering software integrations with other healthcare IT solutions (e.g., EHR, telemedicine apps) and selecting appropriate interoperability standards, like HL7 v.3 or FHIR, for smooth data exchange
Designing UX and UI based on identified roles, usage scenarios, and expected user journeys
Introducing a traceability matrix linking project requirements to design elements

Developing and testing software backend and frontend following iterative cycles
Integrating medical device software with other healthcare IT systems, thanks to HL7 v.3 or FHIR standards
Enabling integrations with smart medical devices and wearables
Implementing risk controls and mitigation strategies
Establishing software version control and configuration management processes.
Creating technical documentation that reflects code and the software architecture for regulatory submissions

Executing verification testing to check that medical device software specifications are met
Performing validation testing in simulated or real-world environments
Testing software usability on a group of representative end users (upon request)
Assessing software security vulnerabilities
Developing comprehensive V&V documentation

Gathering and revising medical device software documentation in line with ISO 13485, IEC 62304, and IEC 82304-1
Preparing a regulatory submission package (e.g., FDA 510(k) Premarket Notification, De Novo, MDR Technical File) according to FDA, MDR, or IVDR requirements for the applicable submission pathway
Finalizing SaMD/SiMD clinical evaluation reports required by FDA and EU regulations
Addressing feedback and questions from the regulatory bodies during the review process, including any HIPAA or GDPR compliance concerns
Managing regulatory clearance timelines and communication strategies during FDA, CE, MDR, and IVDR submission processes

Deploying the medical device software to production
Establishing a post-market surveillance system for ongoing monitoring of SaMD or SiMD performance, clinical safety, and efficacy
Launching procedures for adverse event monitoring and reporting
Planning for post-launch software maintenance and update management

Monitoring of medical device software performance metrics and managing updates, security patches, and versioning of the app
Tracking clinical outcomes and executing post-market clinical follow-up activities
Mapping out medical device software improvements and updates to meet the changing market expectations and address user feedback
Updating documentation to reflect significant software changes and maintaining regulatory compliance as the standards and regulations change (may require additional regulatory submissions if functional changes are substantial)

Wonder where to start with SaMD or SiMD development?

Integrations we implement

EHR or EMR

Our medical software developers integrate SaMD with EHR/EMR systems to enable analytics of clinical records, automate the upload of SaMD insights, and speed up care.

Appar för telehälsa

For patient-facing SaMD and SiMD solutions, we offer integrations with telehealth apps to support remote patient monitoring and smooth chronic disease management.

Patient and doctor apps

Innowise connects medical device software with mobile apps for patients and doctors, making it easy to manage care, track health data, and share clinical information.

Smart medical devices

Med wearable and medical device integrations, medical device software gets access to real-time diagnostic and patient monitoring data, enabling better care insights.

When developing SaMD and SiMD, it’s vital to balance out timelines, safety risks, and compliance concerns and not let them hold the innovative project back. Working in an ISO 13485-certified medical software development company, my team and I know how to handle the technicalities without losing sight of your product vision and are ready to launch your project now.

Anastasia Ilkevich

Portföljförvaltare inom hälso- och sjukvård samt medicinsk teknik

Advanced technologies we know through and through

AI for diagnostics and treatment Big data Internet of Things for medical devices Medical AI chatbots Datavetenskap Healthcare blockchain Computer vision Maskininlärning Virtuell och förstärkt verklighet

Taligenkänning

Predictive analytics for healthcare 3D medical modelling and animation

Choose Innowise as a medical device software development company

At Innowise, we build SaMD and SiMD solutions with speed and precision — never at the expense of safety, quality, or compliance. Backed by ISO 13485 certification and a deep understanding of FDA and MDR regulations, we deliver fully compliant medical device software that is built to last.

Vad våra kunder tycker

Marco Scarpa Teknisk produktchef Beantech S.r.l.

"Det var ett mycket intensivt och effektivt samarbete, alla utvecklare var fokuserade på målen och förberedda på alla de tekniker vi täcker."

Industri IT-tjänster
Teamstorlek 6 specialister
Varaktighet 22+ månader
Tjänster IoT-utveckling

Nikolaj Orlov VD KEYtec AG

"Det jag tyckte var mest imponerande med Innowise var deras förmåga att anpassa sig till våra specifika behov och samtidigt hålla strikta tidsramar. De kombinerade ett kundcentrerat förhållningssätt med starka projektledaregenskaper och såg till att leveranserna höll hög kvalitet och var klara i tid."

Industri Finansiella tjänster
Teamstorlek 2 specialister
Varaktighet 8 månader
Tjänster IT-hanterade tjänster

Gian Luca De Bonis CEO & CTO Enable Development OÜ

"Vi är imponerade av deras flexibilitet och vilja att hitta lösningar på utmanande situationer. De har aktivt hjälpt till i alla typer av situationer. Teamets vilja att leverera optimala resultat säkerställer att partnerskapet blir framgångsrikt."

Industri IT-konsult
Teamstorlek 8 specialister
Varaktighet 36 månader
Tjänster Förstärkning av personalen

FAQ

We understand well the sensitive nature of patient data, and that’s why we implement security into every layer of the software. Our team introduces end-to-end encryption, multi-factor authentication, access controls, and real-time threat detection into healthcare software. Every step of the way, we stay aligned with FDA, MDR, EMA, HIPAA, and GDPR requirements to ensure data stays protected.

There’s no definitive answer to this question, as timelines can vary depending on complexity. Typically, it takes around 6–12 months from the project's inception to the submission-ready MVP, but if you need a more accurate timeline estimate for your software, just skriv till oss.

Absolutely. Innowise designs medical device software with interoperability in mind, supporting HL7, FHIR, and DICOM healthcare standards. Whether you need to connect SaMD with an EHR system or a wearable device, we ensure seamless data exchange and smooth app operation.

Yes, scalability is built in from day one. We use modular, cloud-ready architectures that can grow along with your needs. If, later on, you decide to add new features or will experience an influx of new users, you won’t need to rework your app from scratch, thanks to a thoughtful approach to medical device software architecture.

SaMD and SiMD costs entirely depend on the complexity of the features, required integrations with other IT systems, wearables, medical devices, relevant compliance requirements, and many other factors. If you need an estimate of your project costs, just Kontakta oss, and we will provide you with a calculation based on your project requirements.

With over 18 years of industry experience, Innowise is a medical device software development company that has successfully delivered dozens of projects. We hold an ISO 13485 certification, proving we are well-equipped to develop medical device software and SaMD of any complexity. This certification is essential for FDA and MDR clearance of the software.

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Medical device software development

Vårdföretag som vi betjänar

Standards our quality management rests on

Need a reliable medical software development firm?

Types of medical device software

Sample medical device software we build and implement

Disease diagnostics and treatment planning

Medical imaging

Disease management and monitoring

Disease diagnostics and treatment planning

Medical imaging

Disease management and monitoring

Ready to take your medical device software idea from paper to reality?

Utmaningar som vi löser

Vår efterlevnad

Our medical device software success stories

Benefits of our medical device software development services

Let’s turn your SaMD/SiMD project into reality

Medical device software development roadmap for SaMD and SiMD

Wonder where to start with SaMD or SiMD development?

Integrations we implement

EHR or EMR

Appar för telehälsa

Patient and doctor apps

Smart medical devices

Advanced technologies we know through and through

Choose Innowise as a medical device software development company

Vad våra kunder tycker

FAQ

Kontakta oss

Behöver du andra tjänster?

Låt^●Vi utvecklar programvara tillsammans!

Stäng

Innehållsförteckning

Medical device software development

Vårdföretag som vi betjänar

Standards our quality management rests on

Need a reliable medical software development firm?

Types of medical device software

Sample medical device software we build and implement

Disease diagnostics and treatment planning

Medical imaging

Disease management and monitoring

Disease diagnostics and treatment planning

Medical imaging

Disease management and monitoring

Ready to take your medical device software idea from paper to reality?

Utmaningar som vi löser

Vår efterlevnad

Our medical device software success stories

Benefits of our medical device software development services

Let’s turn your SaMD/SiMD project into reality

Medical device software development roadmap for SaMD and SiMD

Wonder where to start with SaMD or SiMD development?

Integrations we implement

EHR or EMR

Appar för telehälsa

Patient and doctor apps

Smart medical devices

Advanced technologies we know through and through

Choose Innowise as a medical device software development company

Vad våra kunder tycker

FAQ

Kontakta oss

Behöver du andra tjänster?

Låt●Vi utvecklar programvara tillsammans!

Stäng

Innehållsförteckning

Låt^●Vi utvecklar programvara tillsammans!