NSF Clinical Affairs and Regulatory Services

Flashcards covering clinical trial documentation, regulatory requirements (MDR/IVDR), post-market surveillance, and quality management systems for medical devices and pharmaceuticals.

Clinical investigation / study plan and report

Documents required for the creation and application of clinical trials.

Case report form

A specific document created for recording data during clinical trials.

Investigator's brochure

A document created for clinical trials containing clinical and non-clinical data on the investigational product.

Informed consent form

Documentation used for patient information and consent in clinical trials.

PMCF

Post-market clinical follow-up; involves strategies for generating clinical data through studies and surveys after a product has reached the market.

EU MDR

European Union Medical Device Regulation, under which clinical evaluations must be created and updated.

EU IVDR

European Union In Vitro Diagnostic Regulation, which governs the creation and updating of performance evaluations.

Common Technical Documents

Standardized documents created for the registration of pharmaceuticals.

Pubmed and Embase

Databases used for conducting literature searches to obtain preclinical and clinical data for topic-specific summaries.

Benefit-risk assessments

Assessments created to evaluate the safety and efficacy of a medical product.

PSUR

Periodic Safety Update Report.

PMSR

Post-Market Surveillance Report.

PBRER

Periodic Benefit-Risk Evaluation Report.

SSCP

Summary of Safety and Clinical Performance, required for medical devices.

SSP

Summary of Safety and Performance, required for In Vitro Diagnostics (IVDs).

SPC/SmPC

Summary of Product Characteristics, required for pharmaceuticals.

CONSORT and STROBE

Standards and guidelines used for the creation of scientific manuscripts, posters, and abstracts.

Lay Summaries

Summaries of study results written specifically for non-experts or laypersons.

PMS

Post-market surveillance; a robust system that enables trend identification, risk addressing, and continuous product improvement.

Vigilance

The management of post-market surveillance and reporting for medical devices and medicinal products.

QMS

Quality Management System; an efficient system that ensures loyal customers and motivated employees through process optimization and auditing.

Technical Documentation

High-quality documents created in accordance with legal requirements for medical devices and pharmaceuticals.

Regulatory Affairs

Area of expertise focused on regulatory requirements and compliance for medical devices and pharmaceuticals.

Design & Development

Expertise in normative and regulatory aspects of product development within medical technology.