Medical Device Regulatory Compliance Experts
Navigating the complex landscape of MDR, CE certification, NMPA, FDA, and MHRA registration for medical devices with precision and expertise.
Trusted by 200+ medical device companies
TRUSTED BY LEADING COMPANIES
Our Regulatory Compliance Services
Comprehensive solutions to ensure your medical devices meet all MDR, CE, NMPA, FDA, and MHRA requirements efficiently and effectively.
CE Certification
Complete support through the CE marking process, from documentation to final certification for your medical devices.
Learn moreNMPA Registration
End-to-end support for medical device registration in China, including CFDA/NMPA submission preparation and regulatory liaison.
Learn moreFDA Registration
Comprehensive support for FDA registration and compliance, including 510(k) submissions, PMA applications, and establishment registration.
Learn moreMHRA Registration
Expert guidance for medical device registration with the UK Medicines and Healthcare products Regulatory Agency (MHRA) post-Brexit.
Learn moreTechnical Documentation
Expert preparation of all required technical files and documentation to meet MDR, CE and NMPA requirements.
Learn moreCompliance Audits
Thorough audits to identify gaps in your current processes and ensure full compliance with MDR, CE and NMPA regulations.
Learn moreTraining Programs
Customized training for your team on MDR, NMPA requirements, implementation strategies, and compliance maintenance.
Learn morePost-Market Surveillance
Comprehensive solutions for post-market monitoring, reporting, and compliance to maintain certification globally.
Learn moreRegulatory Strategy
Strategic guidance to navigate complex regulatory landscapes and accelerate market access for your devices worldwide.
Learn moreAbout Our Regulatory Expert Team
Shanghai Ouji is a team of seasoned regulatory affairs professionals with deep expertise in medical device regulations across global markets, including EU MDR, China NMPA, US FDA, and UK MHRA requirements.
Our mission is to simplify complex regulatory processes, helping medical device manufacturers navigate compliance requirements efficiently while ensuring the highest standards of safety and efficacy.
Expert Regulatory Advisors
Our team includes specialists with deep knowledge of global regulatory frameworks.
Proven Track Record
Successfully guided hundreds of medical device companies through complex regulatory processes.
Global Perspective
In-depth knowledge of regional requirements across EU, China, US, UK, and other key markets.
Our Regulatory Expertise
Deep knowledge across major global regulatory frameworks to support your market access goals worldwide.
EU MDR Compliance
Comprehensive support for compliance with the European Medical Device Regulation (MDR) 2017/745.
Learn more about MDRCE Marking
End-to-end support for obtaining and maintaining CE marking for medical devices in the European market.
Learn more about CENMPA Registration
Expert guidance through China's National Medical Products Administration registration process.
Learn more about NMPAFDA Registration
Complete support for navigating FDA regulations, including premarket submissions, quality system compliance, and post-market surveillance.
Learn more about FDAMHRA Registration
Specialized support for UK market access through MHRA registration, including UKCA marking and compliance with post-Brexit regulations.
Learn more about MHRAWhat Our Clients Say
Hear from medical device companies who have successfully navigated regulatory challenges with our support.
"The team at Shanghai Ouji guided us through the complex MDR transition process seamlessly. Their expertise saved us countless hours and ensured we maintained market access."
"Their knowledge of NMPA requirements was instrumental in helping our company enter the Chinese market. We couldn't have done it without their guidance."
"Oujie's expertise in both FDA and MHRA registrations was crucial for our global expansion. Their team navigated the unique requirements of each regulatory body with ease."
Ready to Navigate Global Regulatory Compliance?
Partner with our expert team to ensure compliance with EU MDR, CE marking, NMPA, FDA, and MHRA registration requirements, accelerating your global market access.
Contact Our Regulatory Experts
Ready to discuss your regulatory compliance needs? Reach out to our team of experts for personalized guidance on MDR, CE, NMPA, FDA, or MHRA requirements.
Our Location
F16, No.76, Jiuxin Road, Shanghai,China
Email Us
info@ou-jie.com
Call Us
+86 21 3782 9967
WhatsApp Us
+852 4415 3660