Design Control Procedure Bundle | ISO 13485 | FDA QSR Compliant
SKU:
DESIGN-BNDL
$499.00
$499.00
per item
The ISO 13485 Design Control Procedure Bundle includes design control and related procedures that adhere to the design control requirements of ISO 13485:2016 and FDA QSR.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- Includes All Related Forms
- MS Word and Excel Format
- Digital Content - Instant Download
ISO 13485 Design Control Procedure BundleThe Design Control Procedure Bundle includes four (4) commonly purchased design control standard operating procedures drafted in accordance with ISO 13485:2016 and FDA 21 CFR Part 820.
ISO 13485 Design Control Procedure Bundle ContentsThe ISO 13485 Design Control Procedure Bundle includes:
Design Control Procedure -The Design Control Procedure defines a systematic approach applied to medical device product design in compliance with ISO 13485:2016 and FDA Design Control requirements.
Design Review Procedure -The Design Review Procedure is centered on the systematic review of new product design, extensions to existing lines, and design modifications requiring design control. Includes Design Review Forms.
Design Transfer Procedure -The Design Transfer Procedure provides instruction on the transfer of medical devices from design and development to manufacturing.
Design Verification and Validation Procedure -The Design Verification and Validation Procedure addresses the design verification and validation elements of the design and development cycle.
ISO 13485 Design Control Procedures ComplianceThe Design Control Procedure Bundle is FDA 21 CFR Part 820 and ISO 13485:2016 compliant.
For more information about our ISO 13485 Design Control Procedure Bundle contact us at info@aplyon.com
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Design Control Bundle Contents
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Design Control Procedure | ISO 13485 | FDA QSR Compliant
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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).
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Design Review Procedure | ISO 13485 | FDA QSR Compliant
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The ISO 13485 Design Review Procedure establishes the systematic review of medical device development projects at logical points in the design process. The ISO 13485 Design Review Procedure includes detailed review forms to document the entire design review process.
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Design Transfer Procedure | ISO 13485 | FDA QSR Compliant
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The ISO 13485 Design Transfer Procedure governs the transfer of a medical device product and related processes from the development phase to manufacturing in advance of product launch and commercialization.
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Design Verification - Validation Procedure | ISO 13485 | FDA QSR Compliant
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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
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