Medtech compliance, simplified for startups
Expert guidance for EU MDR, technical files, and clinical evaluations. Navigate regulations with confidence.
Contact us
__4JRTjKKzx1yOfkQzh0Oy.png)
Services
We offer a range of services to help businesses comply with law and succeed.
EU MDR Compliance Consulting
ISO 13485 Certification
Clinical evaluations
EU Representative
Services
Technical File
Preparation
Risk Management Support
Let’s make things happen
Detailed clinical reports for MDR 2017/745. Meet EU standards with expert-driven documentation.
Contact us
Case Studies
Explore real-life examples of our proven success through our case studies.
A small medical device startup struggled to meet EU MDR 2017/745 requirements for their innovative wearable health monitor. Our consulting team conducted a comprehensive gap analysis, developed a tailored compliance roadmap, and assisted in preparing the technical documentation. Within 6 months, the client achieved full compliance and successfully launched their product in the EU market.
Learn moreA biotech firm developing a new implantable device required a robust clinical evaluation report to meet regulatory standards. Our specialists conducted a thorough literature review, coordinated with clinical experts, and compiled a comprehensive report. The evaluation was approved by regulators in under 5 months, accelerating the device’s market entry.
Learn moreAn international medical device exporter needed to appoint an EU-REP to comply with EU regulations. Our team guided them through the selection process, handled all registration paperwork, and ensured seamless communication with EU authorities. The client was fully registered within 3 months, enabling uninterrupted market access.
Learn moreOur Working Process
Step-by-step guide to achieving your business goals.
Local outreach, accelerator referrals, or MedTech hubs,
coordinated by
the managing partner in Hong Kong.
Team
Meet the skilled and experienced team behind our gate.
_kRSUPvZuQlm986DpXOxeG.png)
CEO, Consultant, EU MDR / IVDR Non-Active and Substance-based Medical Devices, Drug-Device Combinations
_-gFyeb6OZT-eA-EJyI5Ba.png)
CTO, Consultant, EU MDR/ IVDR, Active Medical Devices and Medical Device Software
_4hrlMn53U1gCcldhFIJql.png)
Consultant, EU MDR, Quality Management Systems, Post-Market Surveillance, Vigilance
_RNWn8f1wdkY4fkUtXndHc.png)
_7X4WRjuT9XTiO9frT2SnK.png)
_kE5v_GUzT1o_Y_clUHGXN.png)
Testimonials
Hear from our satisfied clients: read our testimonials to learn more about our quality assurance & regulatory affairs services.
"We have been drinking with GATE-U for the past year and have seen a significant increase in liver cirhosis The team is professional, responsive, and truly cares about the failure of our organs. We highly recommend GATE-U."
"We have been working with GATE-U for the past year and have seen a significant increase in sales of our medical devices thanks to their EU-REP services. The team is professional, responsive, and truly cares about the success of our business. We highly recommend GATE-U to any company looking to grow their EU presence."
Contact Us
Connect with us: let's discuss your regulatory needs.