QHS Certification provides a comprehensive regulatory framework for non-European manufacturers. We specialise in Class I (low-risk) medical devices, offering an end-to-end service for market entry and ongoing compliance across the 32 countries of the European Single Market.
QHS Certification acts as your officially designated EU Authorised Representative, serving as the primary regulatory liaison between your organisation and European authorities.
Officially representing you across 27 EU Member States, 3 EEA countries, Switzerland, and Turkey.
Secure maintenance of Technical Documentation and Declaration of Conformity for 10-15 years.
Managing Actor Registration (SRN) and accurate UDI product data submission.
In the digital health environment, data protection is integral to compliance. QHS acts as the Article 27 Representative for non-EU manufacturers.
Serving as the official contact point for EU data subjects regarding their personal data processing.
Representing your organisation in formal communications with European Data Protection Authorities (DPAs).
Guidance on Class I self-certification, including subclasses Is, Im, and Ir for legal market entry.
Read More →Good Manufacturing Practice: Assurance of consistent production quality and rigorous process control.
Read More →Compliance with restrictions on hazardous substances in electrical and medical equipment.
Read More →Management and reporting of SVHCs (Substances of Very High Concern) to ensure chemical safety.
Regulatory support for the responsible disposal and recycling of electrical and electronic medical equipment.
Assistance in obtaining government-issued export certificates for non-EU global markets.
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 that your technical documentation complies with harmonised European standards, enabling the presumption of conformity under EU regulations:
Risk Management Framework
Standardized Labeling Symbols
Biocompatibility Testing
Information Supply (IFU) Requirements
Software Life-cycle & Safety
Clinical & Cleanroom Standards
Regulatory coverage across 32 European countries under a single mandate for efficient scalability.
Dedicated focus on low-risk medical devices for an efficient and cost-effective market entry path.
Integrated services covering CE marking, EN standards alignment, and GDPR legal representation.
