~ ~ ~
Warning: date() [function.date]: It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected 'America/New_York' for 'EST/-5.0/no DST' instead in /var/www/custom/archive.cmdm/config.php on line 60

Warning: date() [function.date]: It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected 'America/New_York' for 'EST/-5.0/no DST' instead in /var/www/custom/archive.cmdm/config.php on line 60

Warning: date() [function.date]: It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected 'America/New_York' for 'EST/-5.0/no DST' instead in /var/www/custom/archive.cmdm/config.php on line 60

Warning: mktime() [function.mktime]: It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected 'America/New_York' for 'EST/-5.0/no DST' instead in /var/www/custom/archive.cmdm/config.php on line 60

Warning: date() [function.date]: It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected 'America/New_York' for 'EST/-5.0/no DST' instead in /var/www/custom/archive.cmdm/config.php on line 61

Warning: date() [function.date]: It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected 'America/New_York' for 'EST/-5.0/no DST' instead in /var/www/custom/archive.cmdm/config.php on line 62

Deprecated: Function ereg_replace() is deprecated in /var/www/custom/archive.cmdm/article.php on line 102
Sabic政策旨在确保医疗科技客户达到法规和市场要求 - China Medical Device Manufacturer
CMDM

- English | 中文

Sat, January 20th, 2018

2010年1月CMDM电子快讯 » 行业新闻
Sabic政策旨在确保医疗科技客户达到法规和市场要求


Ricordi仪器是Biorep Technologies公司开发的新型糖尿病治疗设备的部件,采用Sabic Innovative Plastics提供的Ultem HU材料模铸而成,这种产品据称同样受益于该公司的医疗保健产品政策。
Sabic Innovative Plastics宣布推出全面的医疗保健产品政策,旨在帮助客户毫无阻障地快速进入市场。Sabic供应50多种适合生命科学应用的材料,致力于向客户提供符合美国FDA和欧洲医药代理处 (EMEA) 等监管机构的一致性和生物相容性要求的材料。

Sabic公司医疗保健部产品营销经理Tom O’Brien说:“我们的医疗器械客户希望Sabic Innovative Plastics能帮助他们达到美国FDA及其它机构严苛的法规要求,以保障患者安全。我们的解决方案旨在主动制定行业领先的医疗保健产品政策,以简化销售审批以及整个设备使用期间的合规程序。”

Sabic医疗保健产品政策提供以下安全保障:

• 根据ISO10993或USP Class VI标准,预先进行树脂生物相容性评估
• 适用于大多数医疗保健产品的食品接触合规
• 列入美国FDA药品或设备主文件(如有必要,可以提供授权书)
• 适用于产品的配方保密和变动管理程序
• 采用易于辨识的医疗保健产品命名法命名。

其中,配方保密和变动管理政策可以节省大量的时间与成本。据Sabic公司称,上述政策可以避免长达12个月的重新认证延迟,并可节约100万美元以上的成本(具体取决于部件数量)。

Sabic将在美国加州阿纳海姆举办的美国MD&M西部展览会上展出数件受益于新型医疗保健产品政策的医疗器械样品。公司还将在展会上推出适合用于全新工业领域和高性能给药系统的医用级材料,包括用于吸入器械的一系列全新特种化合物。

版权所有 © 2005-2010 医疗设计和制造OEM (CMDM) 本网站所有内容,如未获书面同意,不得以任何形式转载和节录。违反上述声明者,我方将依法追究法律责任。

本期其他行业新闻

相关文章

- 主页 | 当期杂志 | 订阅 | 联系方式 | 关于我们 -©2011 汇科传讯集团 医疗设计和制造OEM 版权所有.