- STORE
- >
- ISO 13485 QUALITY SYSTEM PROCEDURES
- >
- ISO 13485 PRODUCT REALIZATION PROCEDURES
- >
- Technology Transfer Procedure | ISO 13485 | FDA QSR Compliant
Technology Transfer Procedure | ISO 13485 | FDA QSR Compliant
- ISO 13485 and FDA QSR Compliant
- Includes Related Forms
- MS Word Format
- Digital Content - Instant Download
Technology Transfer ProcedureThe ISO 13485 Technology Transfer Procedure provides a phased approach for the transfer of product, equipment, tooling, and manufacturing processes from one location to another.
ISO 13485 Technology Transfer Procedure OverviewThe Technology Transfer Procedure includes detailed guidance on the development of a medical device transfer plan moving a product from one facility to another. The technology transfer planning includes quality planning, supply chain planning, documentation planning, master validation planning, production planning, facilities planning, sterilization planning, and training planning.
The Technology Transfer Procedure is ideal for use in product acquisitions and factory relocation efforts. The phase /gate approach and accompanying forms include in depth action items, milestones and specified requirements that need to be met before continuing on to next phase. ISO 13485 Technology Transfer Procedure ComplianceThe Technology Transfer Procedure is FDA QSR and ISO 13485:2016 compliant.
To learn more about our Technology Transfer Procedure contact us at [email protected]
RELATED LINKS |
|
Customer's also viewed
Medical Device Quality Management System | BASE PLUS SYSTEM
The Medical Device Quality Management System | BASE PLUS is configured for companies engaged in the design and manufacture of medical devices who need only the minimum required content to obtain ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
- Quality Management System Manual
- 38 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download
Medical Device Quality Management System | DESIGN PLUS
The DESIGN PLUS Quality Management System (QMS) is configured for companies engaged in research and development of medical devices but perform no manufacturing (Specification Developers). The Design Plus QMS system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
- Quality Management System Manual
- 46 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download
Medical Device Quality Management System | MANUFACTURING
The Medical Device Quality Management System | MANUFACTURING product is designed for companies engaged in both product development and the manufacture of medical devices. The system is rich in content and provides detailed instruction governing research and development, manufacturing and post commercialization activities. The system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
- Quality Management System Manual
- 60 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download
Medical Device Quality Management System | MANUFACTURING PLUS
The Medical Device Quality Management System | MANUFACTURING PLUS System is our "top line" QMS product configured for companies engaged in the design and manufacture of medical devices seeking ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
- Quality Management System Manual
- 72 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download