Unimed Access specializes in the design, development, and manufacturing of rare medical devices that address unmet clinical needs. Our team of biomedical engineers and regulatory experts work closely with healthcare providers to bring transformative solutions to market.
Our devices meet stringent regulatory requirements with full quality management system implementation.
From concept to clinical validation, we accelerate your medical device development timeline.
We provide comprehensive services for rare medical device development, from initial concept through commercialization, specializing in orphan devices that serve small patient populations with critical needs.
Human-centered design approach with clinical workflow integration and ergonomic optimization.
Read MoreExpert guidance through FDA 510(k), De Novo, PMA, and CE Mark pathways for rare devices.
Read MoreEnd-to-end clinical research services including IDE preparation and post-market surveillance.
Read MoreGMP-compliant scale-up from pilot production to full commercial manufacturing.
Read MoreHealth economics and market access planning for orphan device reimbursement.
Read MoreComplete QMS development compliant with 21 CFR 820, ISO 13485, and MDR requirements.
Read MoreOur integrated approach combines cutting-edge biomedical engineering with deep regulatory expertise to navigate the complex pathway from concept to commercialization for rare medical devices.
Specialized in developing medical devices for rare and orphan indications.
Biomedical engineers, clinicians, and regulatory experts working collaboratively.
Proven track record of FDA and EMA approvals for orphan devices.
Devices currently improving outcomes for patients with rare conditions worldwide.
Whether you're a clinician with an innovative concept or a startup needing full development support, our team can help bring your medical device to life while navigating the complex regulatory landscape for rare disease treatments.