Successfully passed the EU MDR certification, helping you seamlessly connect with notified bodies

In the medical device industry, the implementation of the EU Medical Device Regulation (MDR) has brought new compliance challenges to enterprises. Our professional MDR certification consulting service team will assist you throughout the certification process and achieve efficient coordination with the notified body.

Our professional services include:

Comprehensive gap analysis: Conduct a comprehensive evaluation of your existing quality management system and product technical documents to identify gaps with MDR requirements.

Technical document optimization: Assist in improving key documents such as clinical evaluation reports and risk management files in accordance with MDR Annex II and III.

Quality Management System Upgrade: Help you establish a quality management system that meets the requirements of MDR Article 10 (9).

Announcement Body Connection: As a bridge between you and the announcement body, ensure smooth communication and improve the approval rate.

Continuous compliance support: After certification, we will continue to provide ongoing regulatory updates and compliance maintenance services.




Why choose us?

The team is composed of former announcement agency auditors and senior regulatory experts

100% successful record of assisting clients through MDR certification

Customized service solutions, providing precise support for different product categories

Significantly shorten the certification cycle, saving an average of 30% of time and cost




Let us help you smoothly overcome MDR compliance barriers and quickly enter the EU market. Contact us immediately for free preliminary consultation and pricing solutions.