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Modules/Regulatory Affairs/Summary of Safety and Clinical Performance (SSCP)
Regulatory Affairs

Summary of Safety and Clinical Performance (SSCP)

Author and maintain the Summary of Safety and Clinical Performance for implantable and class III devices, as required by EU MDR Article 32, linked to the product record.

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Part of Regulatory Affairs

ISO TemplatesProduct RegistrationsUDI RecordsGUDID SubmissionsDeclarations of ConformityCE Marking ProceduresEssential RequirementsTechnical DocumentationRegulatory SubmissionsEconomic OperatorsRegulatory CommitmentsRegulatory IntelligenceEUDAMED ReportsNotified Body Management

Key Capabilities

What you get with the Summary of Safety and Clinical Performance (SSCP) module.

Intended purpose written in lay language, with indications, contraindications, and warnings
Clinical benefits summary and residual risks summary
Performance summary with key performance indicators and test results
Clinical evidence summary, including clinical study and literature references and PMCF data
Document version and version date recorded, with the implant card reference where one exists

See Regulatory Affairs in action

Watch how MoniDoseQMS handles regulatory affairs workflows end-to-end.

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Regulatory

Regulatory affairs

What you need for market access: technical documentation, GSPR checklists, declarations of conformity, UDI, EUDAMED and submissions.

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Regulatory

Clinical and post-market

Clinical evidence and post-market follow-up: literature reviews, clinical evaluation, PMS, PMCF and PSUR.

How It Connects

Summary of Safety and Clinical Performance (SSCP) doesn't work in isolation. It connects seamlessly with other modules in MoniDoseQMS for full traceability across your quality system.

Implant CardsClinical EvaluationsTechnical Documentation

Ready to see Summary of Safety and Clinical Performance (SSCP) in action?

Book a 30-minute demo tailored to your regulatory needs. Our team will walk you through how Summary of Safety and Clinical Performance (SSCP) works within your specific compliance context.

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More in Regulatory Affairs

Explore other modules in the Regulatory Affairs category.

ISO Templates

Keep a register of the ISO-related document templates and forms your organization uses. Record the standard and clause each template supports, its version, owner, and review dates, and attach the template file.

Product Registrations

Track product registrations across global markets with status and renewal dates. Maintain a centralized registry of regulatory approvals, clearances, and registrations so you can see your current market access.

UDI Records

Manage Unique Device Identification records for the FDA UDI Rule, EU MDR UDI requirements, and other UDI mandates. Maintain device identifier data and keep your UDI database submissions up to date.

GUDID Submissions

Prepare and track submissions to the FDA Global Unique Device Identification Database. Keep your device listing data accurate and complete, then upload to GUDID yourself and record the submission here. There is no direct API submission.

Declarations of Conformity

Create, manage, and maintain EU Declarations of Conformity as required by EU MDR Article 19. Keep your DoC documents complete, accurate, and revised when changes affect conformity, with records covering the elements EU MDR Annex IV requires.

CE Marking Procedures

Document and manage your CE marking conformity assessment procedures aligned with EU MDR Annex IX-XI. Track conformity assessment routes and notified body interactions, and record that the prerequisites are met before you apply the CE mark.