TRUSTED REGULATORY, QUALITY & CLINICAL EXPERTS FOR MEDTECH DEVICES & DIGITAL HEALTH
FROM FIRST IDEA TO POST-MARKET SUCCESS -- WE HELP YOUR TEAM REACH MILESTONES FASTER WITH LESS RISKPromise
One accountable team, measurable outcomes.
SENIOR-LED DELIVERY & AUDIT READY WORK PRODUCTS
CEO Vision
“We aspire to be the most trusted lifecycle partner guiding the development and commercialization of medical technologies, helping companies navigate FDA and global pathways so patients benefit from safer, more effective healthcare solutions.“
– Jason Gromek, CEO
OUTCOMES WE DELIVER
STREAMLINED PATHWAYS
Submission-ready files.
CLEAR ACTION PLANS
That close findings — and keep them closed
CONFIDENT DIGITAL HEALTH COMPLIANCE
Documentation and evidence that stand up to scrutiny.
FULL-SERVICE CLINICAL LIFECYCLE OFFERINGS
Your partner from study design to approval
COMPLAINTS AND MDRs MANAGED
Risks reduced. Compliance sustained.
CEO Vision
“We aspire to be the most trusted lifecycle partner guiding the development and commercialization of medical technologies, helping companies navigate FDA and global pathways so patients benefit from safer, more effective healthcare solutions.“
– Jason Gromek, CEO
OUTCOMES WE DELIVER
STREAMLINED PATHWAYS
Submission-ready files.
CLEAR ACTION PLANS
That close findings — and keep them closed
CONFIDENT DIGITAL HEALTH COMPLIANCE
Documentation and evidence that stand up to scrutiny.
FULL-SERVICE CLINICAL LIFECYCLE OFFERINGS
Your partner from study design to approval
COMPLAINTS AND MDRs MANAGED
Risks reduced. Compliance sustained.
WHO WE HELP
FUNDED START-UPS AND INNOVATION ECOSYSTEMS
Accelerators, Incubators, university programs
MEDICAL DEVICE MANUFACTURERS
Class II/III; Implants, Capital, Disposables
GLOBAL MANUFACTURERS
Multi-region operations, Cross Border Compliance
DIGITAL HEALTH COMPANIES
Connected devices, Platforms, Clinical Apps
CONTRACT MANUFACTURERS & DESIGN FIRMS
OEM/ODM, Design & Development Partners
PRIVATE EQUITY AND VENTURE FIRMS
Portfolio Company Support, Diligence to Scale
ACADEMIC, NONPROFIT & GOVERNMENT PROGRAMS
Translational Research to Market
Clinical Therapeutic Areas
COMBINATION THERAPIES
Repeatable patterns from these areas help shorten timelines and reduce risk.
FAQs
Do you support digital health software?
Yes. We classify, map requirements, produce the right documentation, and align testing and verification so reviewers can follow the story.
Which submission pathways do you cover?
We support early meetings and full submissions for common FDA and European pathways and prepare the documentation reviewers expect to see.
Can you help with 483s or warning letters?
Yes. We are available as soon as the FDA comes on-site and before. We can assist with the preparation, response, and corrective actions.
Do you run clinical studies?
Yes. Our clinical team supports design, start-up, monitoring, data management, safety, and medical writing across feasibility, pivotal, and post-market work.