Leading the way as one of the independent technical organisations, QHS Certification provides the crucial regulatory foundation that multinational firms require to navigate the EU's complex compliance framework. With our main office located in Tallinn, Estonia, we specialise in auditing, inspection, and certification, thereby bridging the gap between market authorisation and innovation.
For non-European manufacturers, it takes more than just following the instructions to operate in the 32 countries of the European Single Market, and a strong regulatory strategy is necessary. QHS focuses on Low-Risk (Class I) Medical Devices and offers a high-efficiency turnkey solution to MDR 2017/745 compliance.
We aim to simplify the route to a market foothold with every technical file, labeling concern, and quality system reaching the highest level of compliance with European Competent Authorities.
Years of technical expertise
Global Headquarters
Our distinction is that each collaboration is founded on fundamental principles that ensure unparalleled depth and precision.
Our assessment procedures are carried out by market experts, which gives these assessments a level of depth that makes your regulatory submissions capable.
Since we are a separate entity, our certifications represent a globally recognized quality mark and a sure sign of competitive advantage.
We streamline operational processes by using value-based operations, enabling faster market entry without the cost of degrading systems.
QHS Certification enables international distinction, which is coordinated from our headquarters in Estonia. We also enable manufacturers to have the best performance by ensuring that there is full compliance with regulations and educating them in technical and regulatory competencies. QHS Certification is the professional decision when technical excellence and stable availability on the market are of great importance.
"An International Mission of Regulatory Certainty."
