When clinical evidence is needed

Most medical device submissions don't require new clinical evidence — predicate-driven 510(k) submissions, Class I notifications, and many existing-device EU MDR transitions clear on substantial equivalence and post-market data. As part of our Regulatory Assessment work (Regulatory Strategy and Submission), we determine whether your specific device requires clinical evidence. When it does, you typically need clinical work in one of these scenarios.

You need a Clinical Evaluation Report (CER) for EU MDR

EU MDR's elevated clinical evaluation requirements catch many medical device companies off guard. A compliant CER includes a comprehensive analysis of clinical data tied to your specific device's risk profile, intended use, and post-market clinical follow-up to ensure the device meets the applicable General Safety and Performance Requirements (GSPRs). Our team has experience authoring CERs across an array of therapeutic areas and works directly with notified bodies on audit-ready submissions.

You're past first-in-human and need PMCF or PMS planning

Post-market obligations under EU MDR aren't optional, and FDA increasingly expects post-market surveillance to be more proactive than complaint logging. PMCF (Post-Market Clinical Follow-Up) is the proactive piece — actively gathering clinical data on devices already in the field. We help you scope, design, and execute PMCF studies that address residual risks, generate evidence for label expansion, or feed your Periodic Safety Update Report (PSUR) cycle. 

You're submitting a PMA

For Class III devices and high-risk Class II devices that require clinical investigation, our team brings direct submission experience with interventional and observational studies. We package the clinical and regulatory documentation, coordinate with FDA pre-submission meetings, and support your team through the full review cycle.

You're running a clinical trial and need strategic clinical and regulatory oversight

Protocol, informed consent and case report form development, site selection support, trial start-up, monitoring oversight, and study close-out activities. We don't run trials end-to-end as a CRO — we serve as the strategic and regulatory layer between your team and the CRO you choose to execute. This is often the right model for startups and mid-sized firms that want clinical depth without the overhead of a full CRO relationship.

Clinical Affairs services

Clinical Evaluation Plans (CEPs) and Reports (CERs) for EU MDR

We author CEPs and CERs for medical devices ranging from Class IIa to Class III. Each report is built around your specific device's intended use, risk profile, and post-market data and is completed to ensure compliance with the EU MDR requirements. We coordinate directly with notified bodies on submission requirements, audit responses, and periodic updates throughout the device lifecycle.

Post-Market Clinical Follow-Up (PMCF) and Post-Market Surveillance (PMS)

PMCF planning, study design, and execution support — combined with broader PMS system architecture. We help you build complaint handling workflows, adverse event reporting infrastructure, and the data pipelines that feed your PSUR cycle. For EU MDR-regulated devices, this work is non-negotiable; for FDA-regulated devices, it's increasingly expected.

IDE Submission Support

For Class III devices and high-risk Class II devices that require clinical investigation, our team brings direct submission experience with IDE studies. We package the clinical and regulatory documentation, coordinate with FDA pre-submission meetings, and support your team through the full review cycle.

Clinical Trial Management

Protocol, informed consent and case report form development, site selection support, trial start-up, monitoring oversight, and study close-out activities. We work alongside the CRO of your choice as the strategic and regulatory layer that ensures your trial generates the evidence your submission actually needs.

KOL and Surgeon Advisory Board Management

Identifying, recruiting, and managing Key Opinion Leaders and surgeon advisors is one of Kapstone's quiet strengths. Our existing client roster includes surgeons in spine, orthopedic, dental, and inventor-led ventures, and our team's experience working directly with surgeons and KOLs means we can help you build a credible advisory board.

Risk Management Integration (ISO 14971 + Clinical Risk)

Clinical evidence and risk management are similar workflows viewed from different angles. We integrate your clinical evaluation directly with your ISO 14971 risk management activities: design FMEA-clinical alignment, risk-benefit analysis, residual risk acceptability, and the PSUR cycle that feeds it all back together.

International Regulatory Submissions with Clinical Components

Beyond FDA and EU MDR, we support international product registrations including Health Canada (CMDR), ANVISA (Brazil), PMDA (Japan), and other regional regulators. Our team's experience with international submissions gives clients a single point of coordination for global market expansion.

Why Kapstone for Clinical?

Integrated with our regulatory, design, and manufacturing teams

If you are a Kapstone client for design, manufacturing, and regulatory, your clinical work doesn't require introducing a new vendor or onboarding a new team.

We don't try to be a CRO, and that's the point

Larger CROs run trials end-to-end — typically at $500K-$2M+ for full clinical programs. We don't. We provide the clinical evidence work, the CER and PMCF documentation, the IDE and PMA submission support, and the regulatory oversight on trials that other vendors execute. That focus lets us go deeper on the work that actually drives submission outcomes.

Your Clinical Affairs team

Kara Johnson, Vice President of Regulatory Affairs

As part of Regulatory Assessment, Kara determines whether clinical evidence is needed for a given device, and her guidance in the regulatory pathway ensures that clinical work integrates cleanly with your broader submission. Kara and her team give clients a single point of accountability for the full regulatory and clinical envelope.

Get started with Clinical Affairs

If your Regulatory Assessment has identified the need for clinical evidence, we will work with you to integrate this scope of work with your broader regulatory plan.