QHS Certification provides the regulatory foundation that multinational firms require to navigate the EU's complex compliance framework. We specialise in auditing, inspection, and certification for Class I medical devices.
QHS Certification focuses on Low-Risk (Class I) Medical Devices and offers a high-efficiency turnkey solution to MDR 2017/745 compliance.
Coverage
6 Domains
Mapped to EU compliance obligations.
Approach
End-to-end
Documentation + representation + readiness
REP
EU Presence
CE
Market Access
GMP
Quality
REP
EU Representation
Official regulatory liaison between your organisation and European Member State authorities.
CE
CE Mark (MDR)
Technical guidance for Class I self-certification and subclasses (Is, Im, Ir) under MDR 2017/745.
GDPR
GDPR Art. 27
Mandatory Article 27 representation ensuring data protection compliance in digital health environments.
EN
Harmonized Norms
Aligning documentation with harmonised standards (ISO 13485, 14971) for Presumption of Conformity.
GMP
GMP Systems
Production quality assurance and rigorous process controls aligned with European GMP frameworks.
ECO
Environmental
Hazardous substance and waste compliance for equipment (RoHS (EU) 2015/863, REACH, WEEE).
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.
