Transform your patented medical technology from university lab to clinical practice in 3-6 months with our specialized MDR 5(5) documentation service.
Across the EU, universities patent breakthrough medical technologies every year, yet most never reach patients.
CE marking takes years, draining vital resources while research momentum fades and patients wait.
Technical files, QMS setup, risk analysis, and regulatory liaison require scarce expertise.
Finding qualified lab doctors, GMP specialists, QMS and risk professionals is challenging.
Specialized MDR 5(5) hospital exemption documentation service that enables clinical practice in months, not years.
Full MDR 5(5) documentation including Intended Use, ISO 14971 risk files, and QMS-lite procedures.
Comprehensive validation for biocompatibility, sterility, software, and electrical safety.
Instructions for Use, Post-Market Surveillance, training materials, and regulator communication.
Unique value through standardized, scalable regulatory execution with multidisciplinary expertise.
Fast-track from patent to clinic instead of years of CE delay.
Access to multidisciplinary team of lab doctors, GMP specialists, QMS and risk experts.
Growing library of modules making future projects faster, cheaper, and more predictable.
Specialized in taking products from concept to market, including certification
Expert in technical implementation and regulatory compliance
Streamlined approach to get your medical innovation from patent to clinical practice.
Evaluate your innovation and determine MDR 5(5) requirements
Prepare complete technical files, risk analysis, and QMS procedures
Conduct necessary testing and validation mapping
Deploy in clinical practice with training and support
Ready to fast-track your medical innovation? Contact us to discuss your project.
management@sn-force.com
+37128230842
Sergejs Burtovojs
Dāvida iela 4-26, Rīga, LV-1055, Latvija