Define the audience and sources
Map required content to the current CER, labeling, risk, PMS, PMCF, and device information.
Book a Scoping Call Safety and Clinical Performance
SSCP Writing Services for Medical Devices
Summary of Safety and Clinical Performance writing for implantable and Class III medical devices with clear, consistent EU MDR evidence communication.
The IMTS perspective
Evidence that stands up to scrutiny.
The SSCP translates complex technical documentation into an accurate public summary for healthcare professionals and, when applicable, patients. IMTS develops SSCPs that remain consistent with the CER, risk management, labeling, PMS, and PMCF documentation.
An SSCP must be accessible without oversimplifying the evidence or introducing claims that are not supported elsewhere in the technical documentation. Every statement needs careful control of terminology, audience, and source consistency.
Scope of support
What we can deliver.
- 01New and updated SSCPs
- 02Healthcare professional content
- 03Patient facing content when applicable
- 04Cross document consistency review
- 05Notified body comment response support
How we work
A focused path from source evidence to final document.
Translate the evidence
Present safety, performance, alternatives, residual risks, and clinical evidence in precise, understandable language.
Verify consistency
Cross check claims, data, terminology, and conclusions against controlled source documents before review.
Start a conversation
Bring us the document that needs to move forward.
We will help define the scope, source materials, review process, and practical next step.
Book a Scoping Call