- STORE
- >
- ISO 13485 QUALITY SYSTEM PROCEDURES
- >
- ISO 13485 PRODUCT REALIZATION PROCEDURES
- >
- ISO 13485 DESIGN DEVELOPMENT PROCEDURES
- >
- Software Clinical Evaluation Procedure
Software Clinical Evaluation Procedure
SKU:
SOP 7-044
$149.00
$149.00
Unavailable
per item
The Software Clinical Evaluation Procedure governs the clinical evaluation activities, including the assessment and analysis of the clinical safety, effectiveness and performance, of the Software.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR (EU) 2017/745 Compliant
- MS Word Format
- Digital Content - Instant Download
Software Clinical Evaluation ProcedureThe Software as a Medical Device Clinical Evaluation Procedure governs the clinical evaluation activities, including the assessment and analysis of the clinical safety, effectiveness and performance, of Software.
Software Clinical Evaluation Procedure - OverviewClinical evaluation is a systematic and planned process to continuously generate, collect, analyze, and assess the clinical data pertaining to a SaMD in order to generate clinical evidence verifying the clinical association and the performance metrics of software when used as intended.
The Software Clinical Evaluation Procedure provides guidance on three distinct aspects: (1) Valid Clinical Association; (2) Analytical Validation, and (3)Clinical Validation activities. The procedure includes definition of responsibilities, evaluation process flow and methods of generating and assessing relevant evidence used in each area of clinical evaluation. Software Clinical Evaluation Procedure - ComplianceThe Software Clinical Evaluation Procedure complies with ISO 13485:2016, FDA 21 CFR Part 820, and MDR (EU) 2017/745.
RELATED LINKS
|
|
Customer's also viewed
Medical Device Software Development Plan
$149.00
The Medical Device Software Development Plan provides detailed instruction on the creation of a software development plan that is harmonized with the requirements of IEC 62304 and FDA guidance.
- IEC 62304:2015 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Instructive Document
- Instant Download - Digital Content
Software as a Medical Device (SaMD) Development Procedure
$149.00
The SaMD Development Procedure governs the planning and realization of Software as a Medical Device (SaMD) product lifecycle processes. The procedure provides instruction and guidance throughout the software lifecycle and establishes critical linkage to QMS and regulatory requirements.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- IEC 62304:2015 Compliant
- MS Word Format
- Digital Content - Instant Download
Software Validation Procedure | ISO 13485 | FDA QSR Compliant
$199.00
The Software Validation Procedure governs computer systems and medical device software used in medical device development, production and QA activities. The procedure includes a detailed validation protocol with step by step instruction for conducting the validation and generating a validation report.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download
Human Factors and Usability Engineering Procedure
$149.00
The Human Factors Engineering (HFE) and Usability Engineering (UE) Procedure assists medical device design teams in following appropriate human factors and usability engineering processes to ensure new medical devices will be safe and effective for the intended users, uses and use environments.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download