Med Device Advisors Sells Medical Device SOP's
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Categories SOPs_Available SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP
SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP
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This SOP group describes procedures to control the software development and validation process including off the shelf software and 21 CFR part 11 compliance. Select this item to order all software titles at a reduced price $1800 |
$1,800.00
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This SOP describes the risk based software development process and the software life cycle. It covers Level of Concern, Development Plan, Risk analysis, Requirements Specification and Validation. (18 pages) $150 |
$150.00
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This SOP provides guidance to determine Level of Concern as defined by the US FDA for software. (5 pages + 1 report form) $125 |
$125.00
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This SOP defines requirements for configuratiom management including methods to control and number documents and revisions. (5 pages) $150 |
$150.00
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This SOP describes methods to develop a risk based Requirements Specification including Use Case Analysis. (10 pages + 1 report forms) $150
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$150.00
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This SOP describes procedures for conducting Hazard Analysis for software. Software HA is conducted differently than hardware HA. For instance probability is not considered.(13 pages + 3 forms) Webinar slides are included. They explain the SOP in detail and explain the context of the SOP. They could be used for training. $175 |
$175.00
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This SOP controls the process of tracking and resolving development problems and anomalies. One form is included. (5 pages + 1 report form) $150 |
$150.00
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This SOP describes and controls the software validation process. (11 pages + 3 report forms) $200 |
$200.00
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This SOP describes procedures for reviewing source code as part of software validation, (4 pages) $150 |
$150.00
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This SOP describes the procedure for conducting calculations of algorithms as part of validation. (5 pages + 1 report form) $125 |
$125.00
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This SOP describes the procedure for conducting Unit tests. The SOP contains 5 pages and 2 report forms. $125 |
$125.00
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This SOP describes the procedure for conducting software integrated unit tests (5 pages+ 2 forms) $125 |
$125.00
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This procedure describes the procedure for conducting a software system test (5 pages + 1 form) $125 |
$125.00
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This SOP describes the procedure to create electronic records and electronic signatures that are in conformance to Part 11. (5 pages + 3 forms ). Webinar slides that explain the SOP and the context of the SOP are included. These could be used for training. $200 |
$200.00
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This SOP describes the risk based procedures for validation of purchased off the shelf (OTS) software whether used in a device, used in the production of a device or or in laboratory/ Quality systems supporting the device development (8 pages). $150 |
$150.00
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