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Solution

Clinical Training

Equip your team with expert clinical training designed to support success in the medical device and IVD industry.

Training

Practical Clinical Training for Medical Devices and IVDs

Keeping your clinical and regulatory teams trained on the applicable standards, regulations, and best practices is critical for the success of the development, bringing and keeping your medical device or IVD on the market.  Clinical training helps to ensure your staff fully understanding requirements like ISO 14155, ISO 20916, GCP, EU MDR, IVDR, FDA, and project related guidelines that impact clinical investigations and post-market clinical or performance follow-up. 

At Qserve, we are specialized in medical device and IVD clinical training, delivering comprehensive programs designed to fit your organization’s specific needs. Our flexible training solutions include, onsite training courses, interactive virtual training sessions, customized in-company workshops, engaging e-learning modules, live webinars, and on-demand webinars that your team can access anytime. 

Whether you want to onboard new clinical staff, refresh your existing team’s knowledge, or prepare for audits and inspections, Qserve’s trainers are well prepared and experienced to provide up-to-date, practical knowledge that improves compliance and performance. Our courses are a combination on regulatory insight with practical application, enabling your teams to confidently navigate clinical investigations, PMCF or PMPF studies, and Clinical (Performance) Evaluations. 

824
Satisfied Clients
100+
MedTech Trainings
20+
Trainers
24
Years of Combined Experience
Our Services

With expertise in the unique challenges of medical device and IVD clinical activities, Qserve delivers specialized training solutions tailored to your team’s needs:

Post-Market Clinical Follow-Up (PMCF) Training

In-depth courses on developing, implementing, and documenting effective PMCF studies aligned with EU MDR or FDA requirements.

ISO 14155 and Good Clinical Practice (GCP) for Medical Devices

Training on ISO 14155 and GCP principles tailored to the unique aspects of medical device clinical investigations.

Clinical Evaluation and CER Preparation

Guidance on conducting clinical evaluations and preparing robust Clinical Evaluation Reports per regulatory requirements.

Regulatory Requirements for Clinical Investigations

Country specific overview of global regulatory expectations and submission processes for clinical investigations.

IVDR Clinical Performance Studies and ISO 20916 Requirements

Training on planning and conducting clinical performance studies in compliance with IVDR, MDCG 2025-5 and ISO 20916 standards.

IVDR Clinical Performance Evaluation

Training on developing and evaluating clinical performance to meet IVDR and MDCG 2022-2 requirements effectively.

Companion Diagnostics, Clinical Trial Assays and combined pharma studies

Specialized training on designing and managing companion diagnostics, clinical trial assays, and integrated pharmaceutical studies to ensure regulatory compliance and clinical success.

PMCF Surveys

Targeted training on designing, conducting, and analyzing PMCF surveys to gather real-world evidence that supports ongoing device safety and performance.

Clinical Investigations

Training on planning, conducting, and managing clinical investigations to ensure compliance with regulatory standards and study objectives.

Explore Our Full Range of Clinical Training Opportunities

Unlock the knowledge and skills your team needs to excel in medical device or IVD clinical activities. Discover all available courses, formats, and schedules now! 

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FAQ
Frequently Asked Questions About Clinical Training
Still have questions? We are here to help, including with clinical training courses.

Why is clinical training important for medical device companies?

Clinical training ensures teams understand regulatory requirements and best practices, reducing compliance risks and improving clinical trial quality. Gathering clinical evidence is potentially costly; making the right choices can have a significant business impact. 

How does Qserve tailor in-company training to specific needs?

We customize content based on your device type, clinical processes, and team experience to maximize relevance and impact. 

What topics are covered in your e-learning courses?

Our modules cover ISO 14155, ISO 20916, EU MDR and IVDR clinical requirements, GCP, clinical trial management, PMCF, PMPF, and more. 

Can virtual training accommodate global teams?

Yes, our virtual sessions are designed for interactive participation across time zones and locations, and we’re happy to provide a custom training offer tailored to your team’s needs. Contact us to learn more. 

How do on-demand webinars benefit busy clinical professionals?

On-demand webinars allow flexible access to expert knowledge anytime, helping professionals learn at their own pace. Our on-demand webinars are free to watch and include a Certificate of Participation upon completion. 

Where can I find more information and register for clinical training courses offered by Qserve?

On Qserve Learn, our dedicated e-learning platform designed specifically for medical device professionals, you can explore detailed course descriptions, access free resources, and register for our clinical training programs.