Expert support for Medical Devices across the entire product lifecycle, from development to post-market activities.
Medical Device experts who support manufacturers
The regulatory environment for medical device manufacturers is becoming increasingly complex. With the implementation of the EU MDR and IVDR, evolving FDA requirements, and stricter global compliance standards, companies face unprecedented challenges in bringing their devices to market safely and efficiently.
At Qserve we don’t just consult. Our team of experts offers 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, we ensure your devices meet all compliance requirements.
Whether you're a startup bringing your first device to market or a multinational expanding globally, we tailor our services to your needs—offering project-based support, strategic advice, or interim staffing solutions to keep your business moving forward.
Our IVD services cover multiple disciplines. Discover all of them:
Consultancy
We provide strategic regulatory, quality, and clinical guidance to help medical device companies in to bring medical devices to the market.
Audits & Assessments
We conduct in-depth audits and gap assessments to ensure compliance with global medical device regulations, including MDR, IVDR, and ISO 13485.
QA Support
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.
Regulatory Intelligence
We facilitate expert-driven workshops and strategic dialogues to align stakeholders on regulatory, clinical, and market pathways for medical devices.
Training
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.
Interim Support
We provide flexible resourcing solutions like interim experts, project-based support, or full functional outsourcing to extend your team’s capabilities.
Clinical Research
We design and manage clinical investigations that generate robust evidence for safety, performance, and regulatory compliance of medical devices.
Global Market Access
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.
Clinical Trials
Our team is dedicated to driving the advancement of medical technologies and therapies through meticulous and impactful clinical investigations. As a leading contract research organization, we provide comprehensive services supporting the successful design, development, execution, and management of clinical trials.
PMCF Surveys
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.