Gamma Irradiation Sterilization Validation Procedure | ISO 13485 | FDA QSR Compliant
SKU:
SOP 7-036
$149.00
$149.00
per item
The Gamma Irradiation Sterilization Validation Procedure defines the process to validate and monitor medical device products sterilized by gamma radiation. The Gamma Sterilization Validation Procedure applies to all medical devices sterilized by gamma radiation per ISO 11137.
- ISO 11137 Compliant
- ISO 13485 Compliant
- FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download
Gamma Irradiation Sterilization Validation ProcedureThe Gamma Irradiation Sterilization Validation Procedure defines the process to validate and monitor medical device products sterilized by gamma radiation. The gamma sterilization validation procedure applies to all medical devices sterilized by gamma radiation per ISO 11137-1, ISO 11137-2 and ISO 11137-3.
Gamma Irradiation Sterilization Validation Procedure OverviewThe Gamma Irradiation Sterilization Validation Procedure includes instruction on dose mapping, bioburden, sample selection, sample item portion (SIP), microbiological testing, verification dose, confirmatory verification dose experiments, dose audits, dose augmentation, routine monitoring, and establishing product families.
The Gamma Irradiation Sterilization Validation Procedure applies to medical devices sterilized by gamma irradiation in accordance with ISO 11137. Gamma Irradiation Sterilization Validation Procedure ComplianceThe Gamma Irradiation Sterilization Validation procedure is ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11737, FDA QSR, and ISO 13485 compliant.
To learn more about our Gamma Irradiation Sterilization Validation procedure contact us at [email protected]
RELATED LINKS |
Gamma Sterilization Validation
|
Customer's also viewed
Medical Device Sterilization Procedure Bundle
$399.00
The Medical Device Sterilization Procedure Bundle includes QMS procedures related to EO and Gamma Sterilization Validation and Monitoring, Sterile Load Preparation and Release, and Environmental Controls. All of the procedures comply with ISO 13485, ISO 11135, ISO 11137-1,-2 and -3, and 21 CFR Part 820.
- ISO 13485 Compliant
- ISO 1135 Compliant
- ISO 11137 Compliant
- 21 CFR Part 820 Compliant
- MS Word Format
- Digital Product - Instant Download
Medical Device Quality Management System | DESIGN PLUS
$2,699.00
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 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 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download
Medical Device Quality Management System | MANUFACTURING
$2,899.00
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 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 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download
Medical Device Quality Management System | MANUFACTURING PLUS
$3,599.00
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 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 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download