SOFTWARE THAT SAVES LIVES


We specialize in delivering custom medical device software solutions for MedTech companies, ensuring sustained success and long-term growth through our innovative approach.

Our Services

THE RESOURCES YOU NEED


From regulatory to full life-cycle management, we are experts in the MedTech space and are dedicated to showing you how our proven industry expertise makes us the ideal partner for your needs.

Download White Papers

IT'S IN THE PROOF


Discover how we've helped our clients succeed, leveraging our expertise throughout the entire software lifecycle – ranging from design and development to testing and support.

Our References
IR logo

Software as a Medical Device510(k) SubmissionsSoftware Development LifecycleQuality Management SystemsSOP ConsultationStreamlining Documentation

Growing successful companies requires more than good ideas. You need partners as passionate about your mission as you are to get you where you want to go. Our committed teams drive technology solutions, growth, and outcomes for long-term success. We are the right technology partner to help you get from here to there.

What Sets Us Apart

Our commitment to making an impact drives our relationships with customers and our passion for innovation and performance.

SDLC

SDLC

Complete software development life cycle (SDLC) capabilities

510(k) submissions

510(k) submissions

Proven process for 510k submissions, reducing submission time to as short as 80 days

Software as a Medical Device

Software as a Medical Device

Deep healthtech domain expertise, including regulatory and FDA compliance knowledge

Experience

Experience

Experience guiding startups through hypergrowth
Stability

Stability

Longevity and stability throughout the growth lifecycle

Partnership Model

Partnership Model

Relationship-based partnership model to support customers’ internal teams

Our Leadership Team

We are on a mission to improve lives and make a meaningful impact in the world.

Reference Projects

See How We've Helped Our Clients Succeed

GPI USA

Quality Assurance , Documentation, Software Dev.

Dentalive

Quality Assurance , Device Testing, Mobile Applications

Diadem

Quality Assurance , Device Testing, Documentation, Product Design, Software Dev.

Saalt

Quality Assurance , Device Testing, Mobile Applications, Software Dev.

Smart Peak Flow

Product Design, Regulatory , Software Dev.

Healthcare Solution Refactor

Quality Assurance , Device Testing, Documentation, Regulatory , Software Dev.

Software Suite in Healthcare

Quality Assurance , DevOps , Documentation, Software Dev.

Hospital Information System

Quality Assurance , DevOps , Documentation, Software Dev.

Healthcare Therapy Management

Quality Assurance , Documentation

Mekyska

Quality Assurance , DevOps

Patient and Equipment Tracking

Device Testing, Software Dev.

WHAT OUR CLIENTS SAY

TRUSTED BY

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Connect With Us

U.S. Office

1039 Chrome Rd.
Oxford, PA 19363

Headquarters

Vasvári Pál u. 1/C
9024 Győr
Hungary