Expert support for Medical Devices across the entire product lifecycle, from development to post-market activities.
The regulatory environment for medical device manufacturers keeps getting more complex. EU MDR and IVDR implementation, evolving FDA requirements, and tightening global compliance standards mean real hurdles bringing devices to market safely and efficiently. A regulatory partner who covers the full lifecycle, not just one stage of it, is what closes that gap.
Our team combines deep expertise in regulatory affairs, quality assurance, and clinical affairs, providing strategic guidance and hands-on support throughout the entire product lifecycle: from CE marking and FDA submissions to setting up and maintaining quality management systems, managing clinical evaluations, or clinical trial monitoring.
Whether you're a startup bringing your first device to market or a multinational expanding globally, we tailor our support: project-based work, strategic advice, or interim staffing, whichever keeps your business moving.
Qserve organizes its expertise around four device categories, and it's worth knowing which one applies to you. Medical Devices covers products intended to diagnose, treat, or monitor a condition directly. In Vitro Diagnostics (IVD) covers tests performed on samples taken from the body, regulated separately under the IVDR. Combination Devices pair a device with a medicinal product. Companion Diagnostics (CDx) are IVDs tied to a specific therapy, determining who should receive it. Many manufacturers operate across multiple categories, and our teams coordinate across them rather than treating each in isolation.
Not sure where your own device stands? Take our free CE Submission Readiness Check to see which parts of your EU MDR submission need attention before you engage a notified body. You will get an instant readiness score and a personalised view of your gaps in about two minutes.
We provide strategic regulatory, quality, and clinical guidance to help medical device companies in to bring medical devices to the market.
We conduct in-depth audits and gap assessments to ensure compliance with global medical device regulations, including MDR, IVDR, and ISO 13485.
Our QA Support services help you ensure safety, trust, and performance by building and maintaining quality systems that meet global regulatory standards and support your business goals.
We facilitate expert-driven workshops and strategic dialogues to align stakeholders on regulatory, clinical, and market pathways for medical devices.
We deliver tailored training programs that build internal expertise on key positioons such as regulatory , quality and clinical affaires. Discover Qserve Learn and more training opportunities.
We provide flexible resourcing solutions like interim experts, project-based support, or full functional outsourcing to extend your team’s capabilities.
We design and manage clinical investigations that generate robust evidence for safety, performance, and regulatory compliance of medical devices.
We help you get your medical device registered in countries all over the world.From strategic planning to hands-on submission support, our experts guide you through each step of the regulatory process—ensuring your product meets the specific requirements of regional authorities such as the FDA (USA), EU MDR, Health Canada, TGA (Australia), NMPA (China), PMDA (Japan), and more.
We support every phase of a medical device clinical trial, from protocol design to final study report, as a CRO built specifically for device trials rather than adapted from pharma methodology.
Post-market clinical Follow-Up (PMCF) studies have become essential for medical device manufacturers in an increasingly regulated medical world. They provide insights into devices' performance and safety in real-world settings and ensure compliance with regulatory requirements such as the EU MDR and FDA.
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Plan your clinical investigation submission in Germany: ensure process clarity and MDR-aligned documents to avoid delays or questions from the EC and BfArM
Find out the importance of structured, predictable training for manufacturers in the dynamic landscape of medical devices and IVDs.
Regulatory compliance under the MDR and IVDR is non-negotiable. Read the five signs its time for your team to to seek external regulatory expertise.
