Design Transfer Procedure | ISO 13485 | FDA QSR Compliant
SKU: SOP 7-021
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.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- Includes Detailed Forms
- MS Word Format
- Digital Content - Instant Download
ISO 13485 Design Transfer Procedure
The ISO 13485 design transfer procedure provides instruction on the transfer of medical devices from design and development to manufacturing.
ISO 13485 Design Transfer Procedure Overview
The ISO 13485 Design Transfer Procedure ensures the product and processes have been properly transferred prior to the commercial release of a medical device. Our ISO 13485 Design Transfer Procedure is flexible so as to address multiple design transfer scenarios. The ISO 13485 Design Transfer Procedure utilizes a gated approach to design transfer and includes extremely detailed forms that document each phase/gate of the design transfer process.
Design Transfer Planning
A Design Transfer Plan requires review or development of the following specific plans depending on the circumstance surrounding the transfer (i.e. transferring design from R&D center to another country, or from R&D center to an "in-house" manufacturing facility where mfg. related processes were established during the product development cycle):
Design Transfer Planning - Quality
The Quality Plan will consider the P-Spec requirements, qualification requirements, review of current quality controls and update (if required), inspection procedures, sampling plans, calibration, and any open CAPA plans.
Design Transfer Planning - Supply Chain
Review Purchasing/Suppliers: Approved Supplier List, Supplier Audits, Material Safety Data Sheets (MSDS), Letters of Origin for non-US manufacturing sites, Lead Times, Supplier Performance/Issues, NCMR history, and Inventory transfers.
Design Transfer Planning - Documentation
Review Device Master Record (DMR): Create/review master list of documents, freeze DMR prior to transfer, check documentation system compatibilities, translations, and retained records.
Design Transfer Planning - Master Validation Plan
The Transfer Team will develop a Master Validation Protocol addressing all validation activities which will be approved by the team and the Process Development Manager.
Design Transfer Planning - Production
The production plan will consider current inventory status, safety stock, forecasts and trends, capacity and yields, SKU priorities, and ramp up strategy.
Design Transfer Planning - Facilities
Facilities plan will consider work space requirements, required environmental controls, utilities, warehouse and storage requirements, and production layout and flow, etc..
Design Transfer Planning - Sterilization
Sterilization plan will consider existing sterilization method, cycle validation / adoption, cycle parameters, dose, packaging configurations and weight, bioburden, residual testing, etc..
Design Transfer Planning - Training
Training plan will consider resource requirements, transfer staff requirements, transfer site training requirements, training timing and strategy, full production resource requirements.
ISO 13485 Design Transfer Procedure Compliance
The ISO 13485 Design Transfer Procedure is FDA 21 CFR Part 820 and ISO 13485:2016 compliant.
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