Medical Device Software Development for Manufacturers

Our expertise lies in creating secure FDA-cleared SaMD and medical device software. It builds on a foundation of rigorous architecture and proven project management practices.

Our Valued Customers

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health-quest
speclispe
AirMedCare
Thrive
SaintMichaelsMedicalCenter
Face_reality
bioskin-logo
Achelois_biopharma
Ivision
Oculo
eCare_vault
Sighline
moodolog-sm
true-care

Technology That Makes a Difference In People’s Lives

We help you develop medical device software that meets regulatory standards such as FDA or EMA. With the capability of integrating new technologies into existing systems.

Customized Medical Device Software Development Offerings

Medical Device Software for Smart Hospitals

Seamlessly integrate hospital management software with SaMD. Optimize workflows and centralize control over connected medical devices.

Folio3 Digital Health News

Medical Device Software for Home Monitoring

Customize software for in-home medical devices. Connect data with clinicians and help patients through seamless app integration.

Folio3 Digital Health News

Connecting Medical Devices with 3P Software

We Integrate medical device software with telehealth, mHealth apps, and EMRs. We can also make your pharmacy management interoperable, analyze device data, and expedite clinical decisions through quick reports.

Folio3 Digital Health News

Testing and Validation

We put user needs at the core of our rigorous testing and validation processes. This makes the medical device software effective, intuitive and safe for everyone.

Folio3 Digital Health News

Why Choose Us for Medical Device Software Development

Driving Enhanced Outcomes

We help patients manage their health with real-time insights. We reduce human error with precision and safety and assist healthcare practitioners in making quick and accurate decisions.

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Driving Enhanced Outcomes

We help patients manage their health with real-time insights. We reduce human error with precision and safety and assist healthcare practitioners in making quick and accurate decisions.

Personalizing Patient Experiences

We help manufacturers through medical device software development to provide personalized patient experiences.

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Personalizing Patient Experiences

We help manufacturers through medical device software development to provide personalized patient experiences.

Bottom Line Improvement

We reduce healthcare costs by automating tasks and reducing hospitalizations. This leads to significant cost savings and improved financial sustainability and care quality.

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Bottom Line Improvement

We reduce healthcare costs by automating tasks and reducing hospitalizations. This leads to significant cost savings and improved financial sustainability and care quality.

Case Studies: How We Helped

We partnered with healthcare providers and entrepreneurs to solve global health challenges. Learn more about how Folio3 Digital Health uses its clinical brains to deliver meaningful solutions to healthcare organizations, institutions, startups, and support networks.

Folio3 Digital Health Case Study

AiGenics

Folio3 Digital Health Case Study

The Dow University of Health Sciences

Folio3 Digital Health Case Study

Speclipse

Folio3 Digital Health Case Study

Hamzavi Dermatology

Folio3 Digital Health Case Study

PsychPlus

Folio3 Digital Health Case Study

Genopalate

Folio3 Digital Health Case Study

Vahana

Folio3 Digital Health Case Study

Myomo

Folio3 Digital Health Case Study

Triple Ring Technologies

Folio3 Digital Health Case Study

HealthQuest

Folio3 Digital Health Case Study

Maravai LifeSciences

Folio3 Digital Health Case Study

HipLink

Folio3 Digital Health Case Study

Sightline

Folio3 Digital Health Case Study

Igenomix

Folio3 Digital Health Case Study

AMCN

Folio3 Digital Health Case Study

TrueCare LLC

Folio3 Digital Health Case Study

Ivision

Folio3 Digital Health Case Study

Ecare Vault

Folio3 Digital Health Case Study

Achelois Pharma

Folio3 Digital Health Case Study

Face Reality

Folio3 Digital Health Case Study

Thrive

Folio3 Digital Health Case Study

The Neuro Plan

Folio3 Digital Health Case Study

St. Michael’s Hospital

Folio3 Digital Health Case Study

Oculo

Folio3 Digital Health Case Study

AiGenics

Folio3 Digital Health Case Study

The Dow University of Health Sciences

Folio3 Digital Health Case Study

Speclipse

Folio3 Digital Health Case Study

Hamzavi Dermatology

Folio3 Digital Health Case Study

AMCN

Folio3 Digital Health Case Study

Ecare Vault

Folio3 Digital Health Case Study

Face Reality

Folio3 Digital Health Case Study

Thrive

Folio3 Digital Health Case Study

St. Michael’s Hospital

Folio3 Digital Health Case Study

Genopalate

Folio3 Digital Health Case Study

Vahana

Folio3 Digital Health Case Study

Speclipse

Folio3 Digital Health Case Study

HealthQuest

Folio3 Digital Health Case Study

Maravai LifeSciences

Folio3 Digital Health Case Study

HipLink

Folio3 Digital Health Case Study

Sightline

Folio3 Digital Health Case Study

Igenomix

Folio3 Digital Health Case Study

Achelois Pharma

Folio3 Digital Health Case Study

Myomo

Folio3 Digital Health Case Study

Triple Ring Technologies

Folio3 Digital Health Case Study

The Dow University of Health Sciences

Folio3 Digital Health Case Study

Hamzavi Dermatology

Folio3 Digital Health Case Study

Thrive

Folio3 Digital Health Case Study

The Neuro Plan

Folio3 Digital Health Case Study

St. Michael’s Hospital

Folio3 Digital Health Case Study

Oculo

Folio3 Digital Health Case Study

AiGenics

Folio3 Digital Health Case Study

TrueCare LLC

Folio3 Digital Health Case Study

PsychPlus

Folio3 Digital Health Case Study

Ivision

Healthcare Development Tech Stack

We have state-of-the-art technologies to create healthcare solutions that effortlessly integrate with your existing infrastructure while staying ahead of industry trends.

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tech-stack

How Our Software Development Process Work?

01

Consultation

01

We start by understanding your unique needs, goals, and constraints.

02

Design and Development

02

We collaborate and brainstorm to create tailored software solutions.

03

Testing and Quality Assurance

03

We rigorously test the software for functionality, security, and usability.

04

Deployment

04

We ensure your software is up and running smoothly after we make it go live.

05

Training and Support

05

To ensure a seamless product experience for both users and administrators.

Client Testimonials

Kudos to your team for outstanding work in the discovery phase! Your team understood our business and workflows by asking the right questions and extracting the most useful information. Your team's ownership and results-oriented approach are commendable.

Shaukat Zakaria

CEO at HealthQuest

I’d like to thank everyone for their extra work and making the first release possible before the actual date. I'm overjoyed to see the practical aspect of our application come to life today and hoping to build great products with Folio3.

Maker Athian

Founder at iVision

We've successfully completed the first MVP and I appreciate everyone's efforts especially for the identical parts of the apps and now we have a live product on AWS through your excellent work. Thank you !

Maker Athian

Founder at iVision

I appreciate your remarkable work during the  recent Laboratory service phase. Your determination, analytical thinking, and continuous efforts were crucial in overcoming challenges and achieving success. I appreciate your help as we collaborate to create fantastic items.

Maker Athian

Founder at iVision

Folio3 Digital Health Testimonial

Working with the folio3 team has been a great experience. Your dedication, creativity, and adaptability in overcoming challenges for the Moodology app project are truly commendable.

Azhar Ali

Director At AiGenics

Folio3 Digital Health Testimonial
Folio3 Digital Health Testimonial

Team Folio3 brought my dream app to reality, they explained every step to our non technical team professionally. wireframe and design processes were outstanding  & they built stunning and perfectly integrated application. I think both patients and clinic will be significantly benefited.

Elizabeth Miazga

MD FRCSC at Saint Michael's Medical Center

Folio3 Digital Health Testimonial

Our Latest
Healthcare Insights

Frequently Asked Questions

FDA has defined software as a medical device to improve the medical outcomes for patients. They allow the usage of SaMD to provide benefits. The FDA only allows medical device software that they have already approved. They also regulates the medical devices software (SAMD) to make sure that the software in place is safe and relatively risk-free.

Folio3 is a software solution provider delivering software solutions in all domains for over 15+ years. There are multiple reasons why Folio3 is the most ideal company for software development in medical fields. 

The benefits provided follow ISO9001 standards, including medical domain experts in the team, making use of newer technology, and providing extensive documentation. These multiple benefits are critical when hiring the best software companies that are approved by the FDA.

The most optimal way is the standard procedure developed by Folio3 for software medical devices:

 

  • Business case is defined.
  • Stakeholders are called for a meeting.
  • Software requirements are specified.
  • Domain experts analyze the domain and start to design the technical architecture.
  • Folio3 developers start to develop code for the software.
  • The code is simultaneously tested for errors by the software quality engineers.
  • The system is integrated, and the entire system is validated as a single unit.
  • Finally, the usability evaluations, clinical evaluations, and instructions are documented.

This is perhaps the best software development lifecycle for a software medical device as this is extremely detailed, which helps in getting FDA approval as no documents are missing and all standards are met. A working solution is developed promptly, and the software design for medical devices is built to successfully encourage digital health.

The software as a medical device costs a huge amount of money. According to research conducted by Starfish Medical, they concluded that the total amount of capital required to construct a Class II 510(k) FDA-approved medical device would cost around $30 million. The software development and design for medical will cost almost $2-5 million of this total $30 million budget. 

Approval costs for a Class III medical device that is in the process of premarket approval, needs $94 million, with almost 80% spent on testing and revision phases outlined by the FDA. 

To cut extra costs, it is preferred to hire the services of a company that can provide an all-in-one solution package, such as Folio3.

The medical device software development process has several stages that allow the final software for medical devices to be developed. Medical device software companies follow their development processes. 

Folio3 follows a process that is based on the latest international standards, their own company experience, and the rules and regulations of the FDA. The process phases are planning, code development, testing, usability design, hardware integration, and software testing as a single unit. 

The development process of Folio3 ensures that there is no lack in the software and no revisions are needed, which helps cut significant costs.

Do You Have a Question? Get in Touch