Healthcare and Life Sciences

Elevate your MedTech solutions with full development and regulatory support that ensures timely delivery and market success.

WHAT WE DO

Custom software delivery for Healthcare and Life Sciences

Our experience allows us to transform medical products, always keeping patient welfare, business goals and regulatory compliance in mind. Save up to 30% by choosing from the most talented Research & Development teams. 

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Medical devices software development

diagnostic and monitoring solutions | clinical trials | disease treatment

  • Software for clinical equipment: surgery systems, diagnostic systems
  • Software for patient home-usage equipment: home therapy and rehabilitation devices, patient monitoring products and automated drug delivery systems
  • Microcontrollers firmware development: fluids and gases streaming management
  • Device drivers development
  • Interconnectivity
  • Electronic hardware and Human-Machine Interfaces design
  • Medical algorithms
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SaMD – Software as a medical device

e-therapy management | adherence management | clinical trials  

  • Patient engagement solutions: web-based and mobile applications
  • Medical device supporting solutions: data management, patient and doctor dashboards, device maintenance
  • Self-diagnostic applications
  • Cloud migration for scale processing of large amounts of medical data 
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Medical compliance consulting 

Product

  • Medical device definition
  • Medical device & in vitro medical device market introduction preparation
  • Medical device & in vitro medical device market introduction

Business

  • Quality management system (QMS)
  • Consulting & advisory

Safety & maintenance

  • Post-market surveillance (PMS)
  • Vigilance and risk management
  • Data protection
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Medical software integration and interoperability HL7/FIHR

connected health solutions and telemonitoring 

  • Wired or wireless connectivity: WiFi, Bluetooth, RFID
  • Medical and non-medical system integration
  • Interoperability: medical data exchange

Is your product compliant with the new EU Cybersecurity Act? Get it done in 2024

Implementing IEC 81001, IEC TR 60601 and indirectly via some of the national regulations IEC62443 standards by the end of 2024 is crucial to ensure vital cybersecurity measures. We have all the experience you need so your product can meet all mandatory EU requirements. 

FULL CARE OF YOUR NEEDS

Get full support through all the stages of your medical device lifecycle: from concept, through product development, to maintenance

Product concept
Design and development
Market approval
Production

Successful development process – right from the start:

  • conceptualise and visualise your product or product vision through workshops with our experts,
  • get support with establishing Regulatory Strategy, medical device classification and software classification documents,
  • ensure your risk management process is performed according to ISO 14971,
  • have software architects draw initial solution architecture,
  • get assistance in planning and tailoring Medical Device Software Lifecycle Processes according to IEC 62304,
  • implement a proof of concept that will allow you to quickly check your business constraints or crucial technological aspects. 

Product design and development according to agile development lifecycle and in compliance with IEC 62304:

  • Strategy: regulatory requirements, PoC, initial architecture
  • Pre-development: intended use definition, medical device & software classification, regulatory strategy
  • Quality management: support and/or creation of quality management system in line with ISO 13485
  • R&D process: effective process adaptation and adjustment 
  • Clinical trial: support and solution delivery
  • Software risk assessment: compliance check with ISO 1497
  • Documentation: creation and/or review of product design dossier

Smooth market approval process with the support of our experts:

  • gain certainty with Submission Readiness Report, including highlighted gaps,
  • resolve found issues right away,
  • get market approval documentation prepared, e.g. documentation required for CE-marking (MDR), 510(k) submission. 

We create modern healthcare software solutions:
● monitored in real-time,
● auto-scalable using cloud and AI,
● designed with high usability guaranteed by ISO 62366 compliance,
● safe by design and compliant with IEC 62304 and ISO 27001.

You can also have us handle the post-market activities:
● product maintenance,
● L1 – L3 support lines,
● data collection and analysis,
Post-Market Surveillance Activities Management System, 
constant improvements and adaptation to changing requirements.

We guide you through the MedTech regulations

In the MedTech world, meeting regulatory demands is critical. Knowing and complying with the specific requirements of local authorities can significantly accelerate the process of bringing a product to market.

As Healthcare services experts, we understand this industry’s unique challenges. Our team strength lies in extensive domain expertise, medical software proficiency and deep regulatory knowledge. All of which allows us to ensure timely delivery and efficiency within the budget.

OUR APPROACH

We stand by patient-centric approach

All projects we work on within Spyrosoft’s Healthcare and Life Sciences evolve around the patient. We know that the key to exceptional solutions is an innovative technology, user-friendly design, and functionality. We are incredibly proud of every contribution dedicated to improving health. 

Need support with compliance?

To deliver top medical software solutions, we keep up to date with the latest regulations. We know the processes and requirements inside out and are happy to support you in meeting them.

HOW WE CAN HELP YOU

We are an end-to-end software delivery company. Benefit from our vast technical expertise and experience in different domains

Certificates

Meet our expert

Working for the MedTech sector allows me to continuously challenge myself

Krzysztof Minicki
Director of Healthcare & Life Sciences

I’ve been developing software for as long as I can remember. I started as a developer and migrated through many different roles in various IT projects. The knowledge and experience I gained allowed me to achieve a comprehensive understanding of the software development process and tailor it to clients’ needs. I’ve been using this skill for the past few years, i.e. when building medical products. I know how to swiftly and effectively develop software addressing all current regulations that’s both safe for patients and will provide them with tangible benefits.

Krzysztof Minicki

CASE STUDY

MedBand – gesture-tracking rehabilitation device

Business insight: the availability of physiotherapists in the market is severely limited. Patients requiring their assistance are forced to wait long for an appointment, delaying the start or continuation of treatment.   

A solution based on data measured in real-time through movement sensors could support the rehabilitation process, partly replacing the therapist’s role by strictly following the training path. 

Our response: we proposed an end-to-end solution – an activity tracker that enables patient’s efficient facilitation of the physical therapy process. Our team developed the hardware and software design, implementation, BLE communication and backend solutions.   

The solution: equipped with sensors, the band tracks patient’s movements and transmits information on the fly to the mobile application. In the app, the patient can observe, compare and correct the accuracy of their physical therapy exercises with those performed under professional supervision.  

Scope: we covered all stages of the MedBand creation: concept, UI/UX design, implementation and submission. Our team delivered their knowledge and experience in medical device embedded software, HMI and connectivity.  

Case studies

See the success stories of our clients

HL7 services for smoother healthcare communication 

We specialise in HL7 services, making medical document sharing easier for hospitals and clinics. Our team reviews and upgrades existing apps to make document exchange better. We also develop new software for creating and sharing medical documents, all in line with HL7 standards. With our focus on HL7, we aim to simplify healthcare data handling and improve communication in medical settings.

Contact us

See how much you can save

Krzysztof Minicki

Krzysztof Minicki

Director of Healthcare & Life Sciences

+48 600 039 611

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