Empowering organizations globally through rigorous auditing, technical expertise, and internationally recognized certification standards.
Complete compliance ecosystem for international manufacturers targeting the European market.
Mandated legal liaison for non-EU manufacturers across all 32 European Single Market nations.
Self-certification guidance for Class I and subclasses (Is, Im, Ir) under Regulation 2017/745.
Essential data residency and privacy representation for digital health and medical tech abroad.
Aligning Technical Files with EN ISO 13485, 14971, and EU Presumption of Conformity.
Ensuring production consistency and rigorous quality control for medical manufacturing.
Specialized restriction of hazardous substances for electrical medical equipment compliance.
Evaluating Technical Files and systems against EU MDR requirements.
Official appointment of QHS as your European Authorized Representative.
Rigorous verification of compliance documentation and GMP flows.
Official registration with European Competent Authorities and EUDAMED.
Post-market surveillance and continuous regulatory maintenance.
Our turnkey representation has helped international manufacturers enter the European market with absolute speed and compliance.
"QHS Certification provided the perfect turnkey solution for our CE Marking. Their Class I expertise made our EU market entry remarkably cost-effective."
Director, MedTech Asia
Understanding the EU representation process is crucial for your global expansion strategy.
Consult A SpecialistA legal representative required for manufacturers without a physical presence in the EU.
Low-risk devices allow for faster self-certification and lower regulatory costs.
Under Article 27, it's mandatory for firms processing EU citizens' sensitive health data from abroad.
Join international manufacturers trusting QHS for turnkey EU representation and regulatory compliance.