Design Control Procedure | ISO 13485 | FDA QSR Compliant
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The ISO 13485 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.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Includes related forms
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ISO 13485 Design Control Procedure
The ISO 13485 Design Control Procedure defines a systematic approach applied to medical device product design in compliance with ISO 13485:2016 and FDA Design Control requirements.
ISO 13485 Design Control Procedure Overview
The ISO 13485 Design Control Procedure is a mature and robust procedure capturing each phase of the medical device design process. The ISO 13485 Design Control Procedure details how to break down a medical device design project into logical FDA and ISO 13485 compliant phases, identifies departmental responsibilities, and serves as the backbone for medical device design and development activities.
The ISO 13485 Design Control Procedure phases captures idea exploration and the feasibility of potential products in advance of design and development activities.
ISO 13485 Design Control Procedure Structure
The ISO 13485 Design Control Procedure is structured as follows:
Medical Device Concept Phase
The exploration of a potential medical device business opportunity in addressing a customer need.
Medical Device Feasibility Phase
An expansion of the medical device concept phase where customer requirements are researched in greater detail, marketing strategies are conceived, performance specifications are drafted, potential regulatory paths are explored, estimation of costs and initial prototypes may be developed, and potential product features are explored.
Design Control Development Phases
The following activities are performed during the design control development phase:
Medical Device Launch Phase and Design History File (DHF) Closure
The project team completes the commercialization of the medical device and supports the product post-commercialization.
Medical Device Design Control Phase Checklists
The ISO 13485 Design Control Procedure includes lists of tasks to be completed for each project phase with assigned responsibilities for each design and development task.
ISO 13485 Design Control Procedure Compliance
The ISO 13485 Design Control Procedure is both 21 CFR Part 820 and ISO 13485:2016 compliant.
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Design Control Procedure Bundle | ISO 13485 | FDA QSR Compliant
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.
Design Transfer Procedure | ISO 13485 | FDA QSR Compliant
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.
Design Risk Management Procedure
The ISO 14971 Design Risk Management Procedure focuses on design elements of the risk management process. The design risk management procedure is aligned with the requirements of ISO 14971:2012.
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