We are passionate about all AI-powered medical devices. Our holistic approach combines business acumen with a deep understanding of medical regulations. We work with Med-Tech companies developing cutting-edge technologies for digital health on the product concept definition and business strategy development and execution. We have a very strong background in Regulatory Affairs for active medical products and support companies in global market access by assuring products compliance with the worldwide regulations and local law applicable to active medical products, including technical requirements (medical safety, EMC, telecommunications, cybersecurity), and US national regulations Code of Federal Regulations Title 21, European Regulation (EU) 2017/745 (MDR), and other major markets regulations. We offer our expertise in product evaluation projects, certification, and registration including FDA. We also support companies in the development and implementation of the Quality Management System according to international requirements like ISO 9001 and ISO13485, and ISO/IEC 27001 Information Security System.
Company Details
- Employees
- 3
- Founded
- -
- Address
- Aleja Jana Pawła Ii, 27,poland
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- https://rasc.pro
- Keywords
- Strategic management, Regulatory Affairs, Product compliance, Technology roadmap, Business analysis.
- HQ
- Warsaw, Mazowieckie
Rasc Ltd. Questions
Rasc Ltd.'s website is https://rasc.pro
Rasc Ltd.'s LinkedIn profile is https://pl.linkedin.com/company/rascltd
Rasc Ltd. has
3 employees.
View email and phone details for 3
employees at Rasc Ltd..
Rasc Ltd.'s industry is
Business Consulting and Services
Rasc Ltd.'s top competitors are
Apc Pharmlog Sp. Z O.o.,
Ciee - Centro De Integração Empresa-Escola,
Rasc - Rede De Assistência Social Cristã,
Difarma Holding S.p.a.,
Pharmconsult Llc,
Pamed Consulting Karol Pawelec,
Banco Do Brasil,
Secgen,
Jeffco | Capacitación Y Consultoría,
Medireg Pharmaceutical Consulting.
Rasc Ltd.'s categories are Business Consulting and Services
Rasc Ltd.'s founding year is 2021
