Innolitics is a medical device software consultancy specializing in helping companies develop and secure FDA clearance for medical device software. Innolitics focuses on building and validating software for both Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), leveraging a team of expert software developers, AI/ML specialists, cybersecurity professionals, and regulatory consultants.
Over the past 12 years, Innolitics has supported the development and successful FDA clearance of more than 60 medical devices. Their core services include:
- Custom medical device software development
- Regulatory strategy and FDA submission support
- AI/ML algorithm development and validation for medical use
- Cybersecurity assessments and compliance
Their approach is rooted in deep technical expertise and a thorough understanding of US FDA regulatory pathways, making them a trusted partner for companies ranging from early-stage startups to established medical device manufacturers.
Who Uses Innolitics?
Innolitics serves a diverse clientele in the medical technology field. Notable customers include Echo IQ, Bridge Source, AUMI ai, Medweb, OXOS, Transonic, Magnetic Insight, The University of Alabama at Birmingham, CubeClick, NSI, RadUnity, Body Check, VivoVerse, Varian-Mobius, OrthoVentions, Indica Labs, GuidewireRX, Varian Medical Systems Mobius 3D, Matrix MD, Mary Bird Perkins Cancer Center, PhotoniCare, CorticoMetrics, Enlitic, Retrieve Medical, SimBioSys, Valo Health, Envisionit Deep AI, Rology, InVivo Analytics, CIRS (now Sun Nuclear), Dionysus, AI Metrics, and Cube Click, Inc. This range highlights their focus on companies seeking expertise in regulated medical software and FDA processes.
How Was Innolitics Started?
Innolitics was founded by a multidisciplinary team with backgrounds in medicine, engineering, physics, and quality/regulatory affairs. Key founders include Yujan Shrestha, a physician and software engineer specializing in AI/ML and regulatory consulting; J. David Giese, a biomedical engineer and regulatory consultant; Mary Vater, a quality and regulatory affairs expert; Mihajlo Grčić, a physicist; and Reece Stevens, a biomedical engineer with extensive software development experience. Their combined expertise underpins the company's emphasis on safe, effective, and compliant medical technology solutions. More about their background and company history can be found on their About page.
What Makes Innolitics Different?
Innolitics distinguishes itself through its combination of deep technical proficiency and regulatory knowledge. Their track record of building and clearing a significant number of medical devices demonstrates their capability in managing both the technical and compliance aspects of medical software development. Their in-house expertise in AI/ML, cybersecurity, and FDA submissions positions them as a comprehensive partner for medtech companies navigating complex regulatory environments.
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