Clinical Investigation Plans and Performance Study Protocols
When existing evidence is not enough to prove a device or diagnostic performs as claimed, you have to generate new data, and that starts with a rigorous protocol. EvySaif designs and writes clinical investigation plans for medical devices and clinical performance study protocols for IVDs, to the international good-practice standards that regulators and ethics committees expect.
Two disciplines, one standard of rigor
Devices and diagnostics take different routes to new evidence. A medical device follows a clinical investigation; an IVD follows a clinical performance study. Each has its own governing standard and design logic, and we write both.
Devices: clinical investigations under ISO 14155
When a device is novel, extends beyond an equivalent device's intended purpose, or lacks sufficient clinical data, a clinical investigation is required, and for implantable and Class III devices it is generally mandatory. Studies run under EN ISO 14155:2020.
Write the CIP
The Clinical Investigation Plan (CIP) is the governing document, describing study design, objectives, endpoints, subject population, and risk mitigation, aligned with ISO 14155, MDCG 2024-3, and MDR Annex XV. A sound CIP secures ethics committee and competent authority approval.
IVDs: performance studies under ISO 20916
The equivalent for diagnostics is the clinical performance study under EN ISO 20916:2024. The Clinical Performance Study Protocol (CPSP) defines how the study demonstrates that results correlate with the target condition in the intended population, feeding directly into the clinical performance pillar of the PER.
Report on completion
This is distinct from a drug clinical trial protocol, with design logic around diagnostic accuracy, reference standards, and specimen handling. On completion we prepare the clinical investigation or performance study report.
Not a drug trial: device and IVD studies follow ISO 14155 and ISO 20916, not ICH GCP, with design logic specific to devices and diagnostics. We handle both, but they are distinct disciplines.
What we prepare
Clinical Investigation PlansCIPs to ISO 14155 and MDR Annex XV.
Performance Study ProtocolsCPSPs to ISO 20916 and IVDR.
Study synopsesFor early alignment before the full protocol.
IB and consentInvestigator brochures and informed consent documents.
Statistics and endpointsStatistical considerations and endpoint definition.
Study reportsClinical investigation and performance study reports on completion.
How EvySaif helps
We design and write clinical investigation plans for devices and clinical performance study protocols for IVDs, to the standards regulators and ethics committees expect. Our designs are pressure-tested against what reviewers actually ask, and we prepare the completion report as well as the protocol.
Why EvySaif
EvySaif stands among the best research and medical writing consultancies in India, and our protocol experience spans both the device and the diagnostic side. Our designs are clinician-led and pressure-tested against what ethics committees and Notified Bodies actually ask, so the study you run generates evidence that holds up, not data you have to explain away later.
Frequently asked questions
ISO 14155 governs clinical investigations of medical devices; ISO 20916 governs clinical performance studies of in vitro diagnostics. They are the good-practice standards for their respective device types.
No. It follows ISO 14155 and MDR requirements rather than ICH GCP, with design logic specific to devices. We handle both, but they are distinct disciplines.
Yes. We prepare the protocol and, on completion, the clinical investigation or performance study report.
Have a different question?
Tell us about your product, market, and timeline, and a clinician on our team will reply with specifics rather than a sales script.
Request a proposalPlanning a device or IVD study?
Tell us about your product and timeline, and we will come back with a scoped proposal for the dossier and strategy work.
Request a proposal