Customer Requirements Validation Procedure
SKU:
SOP 7-046
$149.00
$149.00
per item
This procedure provides instruction for conducting a Customer Requirement Validation (CRV) for a new medical device in advance of a full market release to obtain user feedback on a specific product configuration and to determine the marketability of a device.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Digital Product - Instant Download
Customer Requirements Validation ProcedureThis procedure provides instruction for conducting a Customer Requirement Validation (CRV) for a new medical device in advance of a full market release. The procedure includes a CRV Template and is ISO 13485:2016 and FDA QSR compliant.
Customer Requirements Validation Procedure - OverviewThe Customer Requirements Validation Procedure guides medical device design teams in the development of a customer requirements validation plan.
The CRV Plan is intended to obtain user feedback in advance of a Full Market Release in order to gauge the effectiveness of the design to meet customer requirements determine the products marketability in the targeted market area. Customer Requirements Validation Procedure - ComplianceThe Customer Requirements Validation Procedure is ISO 13485:2016 and FDA QSR compliant.
For more information about our Customer Requirements Validation Procedure contact us at info@aplyon.com
|
Customer Requirements Validation Procedure
|
Customer's also viewed
Design Control Procedure | ISO 13485 | FDA QSR Compliant
$149.00
The Design Control Procedure defines a systematic approach to medical device design in compliance with ISO 13485:2016 and FDA 21 CFR Part 820 design control requirements and the establishment of compliant Design History Files (DHF's).
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR EU 2017/745 Compliant
- MS Word Format
- Digital Content - Instant Download
Design Verification - Validation Procedure | ISO 13485 | FDA QSR Compliant
$149.00
The ISO 13485 Design Verification and Validation Procedure defines governs design verification and validation activity being conducted as part of medical device development cycle.
- ISO 13485 Compliant
- FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download
Post Market Surveillance Procedure
$149.00
The Post Market Surveillance Procedure governs all post market surveillance activities and provides instruction on: Post Market Surveillance Plans and Reports (Includes Sample Plan); and Post Market Clinical Follow-Up (PMCF) requirements.
- MEDDEV 2.12/1 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR EU 2017/745 Compliant
- MS Word Format
- Instant Download Digital Content