Clinical Services

Medical Devices:

We deliver expert Clinical Evaluation writing services tailored to MEDDEV 2.7/1 Rev. 4, MDR (2017/745), and MDCG guidance. SRAMS services cover the full lifecycle of the device studies with sound systematic literature analysis, equivalence assessments, evaluation to meet notified body expectations and report submission for the device approval. 

With deep regulatory expertise, we help manufacturers to maintain compliant and defensible clinical evidence to support CE marking, and other regulatory approvals. 

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Services:

• Clinical Investigation 

• Clinical Evaluation

• MDR 2017/745, Annex XIV Gap Assessment

• Technical Documentation Support

• Post Market Clinical Follow-up

• Post Market Surveillance

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In-Vitro Diagnostics:

​We deliver specialized IVD performance evaluation and clinical evidence development services in full alignment with EU IVDR (2017/746), MDCG guidance, and international standards including ISO 20916, ISO 14155, and ISO 15189.
SRAMS provides end-to-end support across the performance evaluation lifecycle — from scientific validity assessment, analytical and clinical performance studies, to systematic literature review, equivalence demonstration, and comprehensive performance evaluation report (PER) preparation in accordance with Annex XIII of the IVDR. 

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Services:

• Performance Evaluation Studies​​​​

• Clinical Performance Studies 

• Analytical Method Evaluation

• Software & Algorithm Clinical Evaluation

• Post-Market Performance Follow-up (PMPF)

• Regulatory Performance Dossiers & Technical File Support