Authorized European Legal Representation
We provide rigorous compliance representation and technical file triage for global manufacturers entering the European Union.
Five Specialized Compliance Sectors
Our technical specialists provide dedicated document reviews and legal representation across five core product categories.
MDR Alignment
IVDR Compliance
Cosmetics Safety
Technical file triage and authorized representative services for Class I, IIa, IIb, and III medical devices.
Rigorous documentation scrutiny and legal representation for diagnostic systems under European IVD regulations.
Safety assessment review and product information file curation for cosmetics entering the European market.
PPE Verification
Consumer Goods
Authorized representative services and technical file triage for personal protective equipment categories.
General product safety directive alignment and border-control clearance for global consumer brands.
Rigorous Technical File Review
Our worldwide team offers assistance in reviewing your technical documents prior to your first submission to your Notifying Body.
Although no consultants can assure success in CE MDR submissions, our team possesses a deeper contextual awareness of Asian culture, allowing us to align more effectively with European regulatory requirements.
Singapore and European Pathways
Singapore Registration
Bilingual SME Support
We bridge the gap between European and Asian markets. Our Singapore-based consultants guide manufacturers through HSA medical device registration and local compliance requirements.
Our team is proficient in both English and Chinese, facilitating effective communication. We bridge communication gaps and address cultural differences.
Secure Your European Market Access
Partner with local legal representatives who actively defend your status. Contact us and submit your technical files for an initial regulatory review.