Medical Device Software Development Services

We offer comprehensive medical device integration and development services that comply with the strict quality standards of the healthcare industry. Enhance patient care, improve diagnostic precision, streamline clinical workflows, and ensure secure data management— whether it’s SaMD development or integration with healthcare systems.

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Enterprises & Startups

Fueling the Innovation in Medical Device Industry

The breakthroughs in non-invasive surgical devices, interventional cardiology, and implanted medical technology are driving the rapid expansion of the U.S. medical device market. An anticipated 8% compound annual growth rate over the next ten years indicates that demand for orthobiologics, cardiac stents, spinal implants, and minimally invasive devices like laparoscopic instruments is rising. Furthermore, the use of nanotechnology in medicine is expanding at a rate never seen before, especially in the treatment of cancer and illnesses of the central nervous system.

At Folio3, we offer comprehensive medical device software development, integrations, and testing services. We have experience writing software for sophisticated patient monitoring systems, connecting hardware with electronic health record systems, and doing thorough testing to guarantee regulatory compliance. Bring SAFE, SMART & Effective medical device software to market.

Comprehensive Medical Device Software Development Solutions

SaMD (Software as a Medical Device) Development

Get hold of software as a medical device (SaMD) that complies with FDA’s 21 CFR Part 820 and ISO 13485. Get our assistance in the design, development, and validation of medical device software solutions that deliver diagnostics and therapeutics coupled with monitoring capabilities.

SaMD (Software as a Medical Device) Development

Mobile Health (mHealth) App Development for Medical Devices

Our expertise is not limited to developing mobile health applications but also interfacing them with medical device software, enabling patients and healthcare providers with the right tools to manage and track their health in real-time.

Mobile Health (mHealth) App Development for Medical Devices

Innate Systems for Medical Devices

We deliver embedded software for medical devices used as implantables, wearables, and diagnostic tools. Capture reliable and real-time data and make your operations secure and scalable, meeting all the medical standards.

Innate Systems for Medical Devices

Cloud-Based Software Development

Level up with advanced cloud technologies like AWS and Azure so that your medical device software operations can be secure and scalable as you expand your healthcare business. Securely store data for it to be accessed remotely and analyzed in real-time while complying with HIPAA and GDPR standards.

Cloud-Based Software Development

Compliance with Global Regulatory Standards

We prioritize building our medical device software following the guidelines set in the global regulatory standards, including FDA, CE Marking, and ISO 14971. Ensure that your medical device software is not only market-leading but also checkmarks industry acceptance.

Compliance with Global Regulatory Standards

Whom We Serve

Medical Hardware Manufacturers

Healthcare Organizations

Healthcare Platforms & Startups

Hospitals

Pharma Companies

Health Tech Consumer Enterprises

Medical Device Software Implementation for Smart & Continuous Care

Advanced In-Hospital Medical Devices

Smart Software for At-Home Devices

On-Body Wearable Device Software

Medical Device Integration Services

Effortless Integration with Healthcare Systems

IoT-Enabled Medical Device Connectivity

Wearable Device Integration with Medical Platforms

Medical Device Integration with AI Systems

Telehealth Platforms Integration with Medical Hardware

Connectivity for Home Healthcare Devices

Case Studies: Real-World Success Stories

AI-Driven Diagnostics Tool for Early Skin Disease Detection

Our AI-powered diagnostics tool reduced diagnosis time. It uses machine learning algorithms for early detection of skin diseases, improving both accuracy and speed in clinical workflows.

Wearable Devices Companion Application

A companion application for two wearable devices: the Pain Relief Controller and the Smart Patch. Its intuitive interface enabled users to read sensor data from the devices easily. The integration allowed users to monitor pain relief progress and adjust settings accordingly.

Neuro-Robotic Arm Brace Companion App

An Android companion app for a portable neuro-robotic arm brace designed to help patients with partially paralyzed limbs regain control over movement. The app allows users to initiate and control movements using their biological signals, facilitating real-time rehabilitation.

Exercise Machine Companion Platform

A companion platform for fitness equipment, such as the "Vahana 360" exercise machines, It allows users to track their workouts, schedule exercise sessions, and visualize their fitness goals. The personalized recommendations and predictive analytics monitored fatigue and optimized workout efficiency.

Our Tech Stack for Wearable App Development

Agile Medical Device Software Development Process

01. Ideation & Feasibility

We study the market, evaluate viability, and create early prototypes. To ensure a smooth transition from conception to development, a strong regulatory strategy is created to satisfy all compliance requirements.

02. Software Design & Development

Our group develops and designs medical software by IEC 62304 criteria. To make sure the product is safe, useful, and compliant, we draft thorough project roadmaps and solicit input.

03. Medical Device Validation Services & Testing

Throughout the software lifecycle, we verify and validate designs to make sure all performance, security, and compliance parameters are satisfied.

04. Deployment & Maintenance

Once development is complete, we handle product deployment and provide continuous maintenance, including frequent updates, bug fixes, and post-launch support to ensure long-term compliance and performance.

FAQ's

What is medical device software development?

The process of designing, creating, and testing software that either functions as a standalone medical device (also known as SaMD) or as a component of another medical device is known as medical device software development (SaMD). For the sake of patient safety and data security, the software must adhere to stringent regulatory requirements, such as IEC 62304 or 21 CFR Part 820 of the FDA. There are several steps in this process, including design, implementation, verification, and validation. Software for medical devices can be used for several purposes, such as monitoring, diagnosis, and therapy.

What is an example of software as a medical device (SaMD)?

A mobile app that analyzes medical pictures for diagnostic purposes, such as AI-driven radiology applications that assist in identifying illness indications in X-rays or MRI scans, is an example of Software as a Medical Device (SaMD). Another illustration would be a smartphone app that tracks individuals with long-term illnesses like diabetes or heart disease and gives doctors access to real-time health information. Even though these programs are not physically integrated with medical devices, they nonetheless have to adhere to safety and effectiveness regulations.

What is an example of medical device interoperability?

The capacity of various medical systems and devices to effortlessly communicate, understand, and use data is known as medical device interoperability. An EHR/EMR system that connects with a blood glucose monitor is one example. Doctors can remotely check on their patients’ glucose levels because of the monitor’s ability to automatically send data to the patient’s electronic health record. Interoperability also includes wearable technology that sends vital indications in real time to healthcare platforms.

How do we perform QA and medical device software testing along with our medical device software development?

To guarantee compliance, safety, and functioning, medical device software undergoes rigorous and organized testing and quality assurance procedures. It includes:

Unit testing is used to confirm that each component functions as planned.
Testing for integration verifies that various software components or hardware units work well together.
Validation testing to make sure the program operates as intended in practical settings.
Usability testing to make sure medical personnel can easily navigate the software interface.
Testing for cybersecurity to guarantee that private patient information is protected.
Regulations like IEC 62304, which stipulate particular software lifecycle procedures for medical device software, must be complied with by these tests.

AI Product Development in Healthcare

Healthcare Interoperability

Telehealth Product Development