“We're dedicated to crafting your global strategy from the initial concept to achieving global market access.”

Qserve is a worldwide consultancy focusing on regulatory affairs, quality assurance, and clinical trials for MedTech businesses. The company works to give access to medical device and in vitro diagnostics manufacturers throughout the world in terms of regulatory approval and maintaining compliance. The approach taken at Qserve is business-centric while offering pragmatic solutions. Its focus is on aiding clients to overcome regulatory, quality, and clinical challenges with a view toward patient safety and advancing biomedical technology. The company boasts the importance of a diverse global team that shares expertise and dedication to high standards of quality, competence, and customer service.

Medical Device and In Vitro Diagnostics Regulatory Consulting Services

In Vitro Diagnostics Consulting Services

Qserve offers regulatory consulting services to the IVD and CDx sectors, which are customized according to the specific needs of the clients. With a global team of IVD regulatory specialists, Qserve guides the clients through the entire product lifecycle to ensure compliance with complex regulations and optimize efficiency at every stage. The company's IVD services encompass compliance and needs assessment, GAP analysis, strategic planning, and the design and development process, both in accordance with local and global regulations.

The CDx service, on its part, offers support to the firm in the way of due diligence, interim, and ad hoc support in addition to IVDR training. In addition, it assists clients with US FDA submissions in the form of PMA, pre-submission, and DeNovo 510(k), and on EU-specific services including IVDR support, transition timelines, and CE mark assistance.

Qserve provides a smooth transition from IVDD to IVDR, and it includes Notified Body support besides post-market surveillance, post-market clinical follow-up, and vigilance. Utilizing a practical and client-centered approach, Qserve can help IVD and CDx manufacturers navigate the complexities of regulatory compliance and market access across different regions, ensuring that diagnostic solutions remain safe and effective.

Medical Device Regulatory Consulting Services 

Qserve specializes in delivering tailored regulatory consulting to meet the unique needs of the medical device industry. Through experience with the intricacies of medical device development and regulation, Qserve can support its clients at any stage of the product life cycle-from concept to commercialization. The company's highly qualified team provides strategic input that will help clients succeed in the competitive healthcare market. This includes regulatory compliance, optimization of product design, and optimization of manufacturing processes.

Qserve offers compliance and needs assessment, regulatory and clinical strategy development, and US FDA submission support for PMA, pre-submission, and DeNovo 510(k). It also provides due diligence, GAP analysis, and submission file/documentation support to ensure a smooth path to market approval. It also offers Notified Body-like review services and expertise in quality management and local representation.

Qserve is tailored for the needs of startups by navigating regulatory challenges and putting together efficient processes. Their service is also provided for the EU AI Act to ensure alignment with emerging regulations. Software-based insights, through the InSight platform, make Qserve provide their clients with timely information on any updates from regulatory authorities for enhanced regulatory intelligence. The company gives medical device manufacturers practical solutions that will guarantee regulatory compliance and market success.

Medical Device Registration

Qserve provides medical device registration services for manufacturers looking for easy market access by simplifying the complex landscape of international regulations. Through its global team of experts, the company helps clients identify markets that are more potential for registering devices with adequate strategic guidance on market access, regulatory compliance, product safety, performance testing, and certification.

Qserve's registration services cover Europe, the Americas, Asia-Pacific, Oceania, and the Middle East. In Europe, Qserve offers CE marking for medical devices and IVDR. In the UK, Qserve offers UKCA certification. In the Americas, Qserve supports FDA medical device registration and Health Canada registration for both medical devices and IVDs.

For Latin American markets, Qserve provides services on Anvisa registration in Brazil, Cofepris in Mexico, and local registration in Colombia. In Asia-Pacific, the company provides registration services for China's NMPA, India, Malaysia, Thailand, Singapore, and South Korea. Qserve also supports TGA registration in Australia and WAND registration in New Zealand.

Furthermore, Qserve offers SFDA registration services in Saudi Arabia and supports registration in other countries around the world. They provide their clients with international regulatory compliance support in order to maintain product quality and safety standards while easily entering the market.

Jan van Lochem - CEO & Partner

“Our mission is to help improve patient safety and health by supporting the advancement of biomedical technology.”