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ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package
The ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package specifies the requirements and procedures to implement a quality management system for an organization that needs to consistently meet regulatory requirements applicable to medical devices and related services. The guidance standard ISO/TR 14969 provides approaches to establish objectives, implement, monitor and measure the processes to improve performance. The requirements and process approach are relevant to any regulated organization that designs and develops, produces, installs or services medical devices or provides related services.
Total savings of 30% off the individual list price.
Price: $219.00
ISO 11137 - Sterilization of Health Care Products Package
The ISO 11137 - Sterilization of Health Care Products Package provides the requirements for developing, validating and routinely controlling the
sterilization process of medical devices.
Total savings of 25% off the individual list price.
Price: $236.00
ISO 10993 - Biological Evaluation of Medical Devices Package
The ISO 10993 - Biological Evaluation of Medical Devices Package has an array of standards on testing, the identification / quantification of degradation
products and other general biological evaluation of medical devices. The general biological evaluation of medical devices standards in this package include
basic evaluation and testing, sterilization residuals, limits for leachable substances, and the preparation of samples / reference materials for testing.
The referenced products are for the identification / quantification of degradation products are metals / alloys, ceramics and polymeric devices.
These particular standards are supported by a toxicokinetic study design standard and framework standard for potential degradation products.
The medical devices tests in this package are for system toxicity, hypersensitivity, local effects after implantation, genotoxicity, carcinogenicity,
reproductive toxicity and interactions with blood. This package is complete with the entire collection of ISO 10993 standards.
Total savings of 33% off the individual list price.
Price: $983.00
Biological Evaluation
of Medical Devices Standards Package
More than 15 standards have been complied to create the Biological Evaluation of Medical Devices package. For your convenience it includes animal welfare requirements,
ethylene oxide sterilization, identification and quantification of potential degradation products, limits for leachable substances, clinical investigation plans
and medical devices for human subjects.
Price: $495.00
Cardiovascular Medical Device Package
This Cardiovascular Medical Device Package includes the safety, monitoring and performance requirements for the more frequently used cardio medical devices.
The package consists of standards that envelope cardiac monitors, sphygmomanometers, electrocardiographs, ECG cables / lead wires / electrodes,
blood pressure transducers and defibrillator devices. This 13 standard Cardiovascular Medical Device package is essential.
Price: $954.00
Health Informatics - Patient Healthcard Data Package
The Health Informatics - Patient Healthcard Data Package provides the platform for developing the structure of the patient healthcard data.
The structure consists of device data, identification data, administrative data, clinical data, electronic prescription, security data and limited / extended clinical data.
Additional standards are included that establish a common framework for the content / structure, architecture for electronic health records, physical
characteristics of the healthcard and good principles and practices for a clinical data warehouse.
Total Savings: 20% of individual purchase price.
Price: $414.00
ISO 594 - Conical Fittings Package
The ISO 594 - Conical Fittings Package specifies the requirements for conical lock fittings with a 6% taper. It covers conical fittings made of rigid and semi-rigid materials to be used with hypodermic needles and syringes. Test methods for gauging and performance are also included.
Price: $121.00
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