At QHS Certification, we provide a complete regulatory ecosystem for non-European manufacturers. We specialize in Class I (Low-Risk) Medical Devices, offering a "Turnkey" solution to enter and sustain your presence in the 32 nations of the European Single Market.
Official mandatory representation for manufacturers outside the European Union. We act as your legal liaison with European Competent Authorities, ensuring continuous compliance with EU MDR and relevant directives.
"Product safety is incomplete without data privacy."
Acting as the primary point of contact for EU citizens regarding their personal data under GDPR legislation.
Representing your firm before European Data Protection Authorities (DPAs) for all regulatory inquiries.
Ensuring data processing activities meet the strict requirements of the EU digital health ecosystem.
Guidance for Class I self-certification and subclasses (Is, Im, Ir) to ensure legal market entry.
Good Manufacturing Practice: Specialized auditing to ensure production consistency and quality control.
Restriction of hazardous substances (2015/863/EU) for electrical medical equipment compliance.
Verification of chemical safety to ensure products are free from Substances of Very High Concern (SVHC).
Effective management of disposal and recycling requirements for electronic medical devices.
Procurement of government-issued export certificates for non-EU global markets through official channels.
Single-audit program facilitation for optimized regulatory access to USA, Canada, Brazil, Japan, and Australia. Streamline your global market expansion with one audit cycle.
We ensure your Technical Files meet the rigorous "Harmonized Standards" required for the Presumption of Conformity within the European Union medical framework:
QMS for Medical Devices
Risk Management Framework
Standardized Labeling Symbols
Biocompatibility Testing
Instruction for Use (IFU) Requirements
Software Life-cycle & Safety
Clinical & Cleanroom Standards
Comprehensive coverage across 32 European nations with a single, consolidated mandate for easier scalability.
We specialize specifically in low-risk devices, enabling faster and significantly more cost-effective market entry for our clients.
From CE Marking and EU Harmonized Standards to GDPR legal representation, we manage every single legal requirement end-to-end.