Clinical Strategy Support

PMCF Surveys

Expert Clinical Strategy Support for Medical Devices and IVDs

A strong clinical strategy is essential for bringing safe, effective, and compliant medical devices or IVD’s to market. From first-in-human trials to post-market clinical follow-up (PMCF) studies (medical devices) or post-market performance follow-up (PMPF) studies (IVD’s), a well-defined clinical strategy ensures alignment with regulatory expectations, efficient resource use, and successful product approval.

Qserve's Clinical Strategy Support provides expert guidance along the clinical life cycle of your medical device or IVD. Our consultants help you create a clinical strategy that is aligned with your device's risk class, intended purpose, and target markets, with full compliance with EU MDR, FDA, ISO 14155, ISO 20916 and other applicable standards. We assist with clinical development plans (CDPs), clinical evaluation plans (CEPs), study design, and clinical evidence mapping to support your regulatory and business goals.

Why Choose Qserve for Your Clinical Strategy Support?

At Qserve, we focus exclusively on medical devices and IVD’s, combining deep regulatory knowledge with clinical expertise to design effective, compliant clinical strategies. Our team of experienced consultants understands the unique challenges of medical device development and the expectations of approval authorities such as FDA and Notified Bodies, enabling us to deliver tailored, high-value strategic solutions that align with both regulatory requirements and your business objectives.

Our Services

With a deep understanding of the unique challenges in medical device and IVD development, Qserve offers specialized clinical strategy support to build effective, compliant, and tailored evidence-generation plans.

Clinical Development & Performance Planning

We design structured Clinical Development Plans (CDPs) for medical devices or Clinical Performance Plans (CPP’s) for IVD’s that align your clinical activities with regulatory expectations and product goals.

Clinical Evaluation Strategy

Qserve supports the development of Clinical Evaluation Plans (CEPs) and Reports (CERs) for medical devices, as well as Clinical Performance Plans (CCPs) and Reports (CPRs) for IVDs, ensuring a robust clinical evidence pathway under MDR, IVDR, and global standards.

Study Design & Protocol Development

Our experts help create scientifically sound, regulation-aligned study designs and protocols tailored to your device type and risk classification.

Clinical Evidence Gap Analysis

We assess your existing clinical data against MDR, IVDR, FDA, ISO 14155 or ISO 20916 requirements to identify gaps and guide next steps for compliance.

PMCF Strategy & Planning

Qserve develops Post-Market Clinical Follow-up (PMCF) strategies for medical devices or Post-Market Performance Follow-up (PMPF) strategies for IVD’s that meet MDRR/IVD requirements and maintain long-term safety./p>

Regulatory Alignment & Roadmapping

We provide clinical-regulatory roadmaps that integrate study planning with submission timelines, accelerating approval and minimizing compliance risks.

Clinical Evaluation Report (CER)/Clinical Performance Report (CPR)

Qserve develops comprehensive Clinical Evaluation Reports (CERs) for medical devices or Clinical Performance Reports (CPRs) for IVDs that demonstrate the safety, performance, and clinical benefit of your medical device or IVD in full alignment with EU MDR / IVDR and MEDDEV 2.7/1 Rev. 4 (medical devices)/MDCG 2022-2 (IVDs).

Successful Submission to Ethics Committees (EC) and Competent Authorities (CA)

Qserve supports the preparation and submission of high-quality clinical documentation to Ethics Committees and Competent Authorities, ensuring regulatory compliance and smooth trial approval.

Book Your Free 30-Minute Consultation

Take the first step toward a smarter, compliant, and effective clinical development plan. Whether you’re navigating EU MDR or IVDR, planning your first clinical trial or clinical performance study, or refining your clinical evidence strategy. Qserve’s experts are here to help.

Book your free 30-minute consultation with one of our clinical strategy specialists.
We'll review your current approach, identify gaps, and provide initial guidance tailored to your device and regulatory goals.

Schedule a Meeting

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FAQ

Frequently Asked Questions About Clinical Strategy Support

Still have questions? We are here to help, including with clinical strategy support.

Clinical strategy support involves developing a comprehensive plan to generate the clinical evidence required for regulatory approval and market access of a medical device or IVD.

Under EU MDR or IVDR, devices must be backed by robust clinical evidence. A clinical development strategy ensures your studies, evaluations, and PMCF activities are aligned with these stricter requirements.

We can assist creating Clinical Development Plans (CDPs), Clinical Evaluation Plans (CEPs), Clinical Performance Plans (CPPs), study protocols, regulatory roadmaps, and gap analyses based on your device’s needs.

Yes, we support clinical strategies across the device lifecycle, from initial trial design to PMCF planning and implementation.

Our experts work cross-functionally across regulatory and clinical domains to ensure your clinical strategy supports submission success and long-term compliance.

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