北京百力诺思医疗器械科技有限公司

百力诺思医疗(P&L SCIENTIFIC)是提供医疗器械国际注册以及市场咨询的专业服务公司，业务涉及医疗器械，体外诊断试剂产品的国际注册，包括美国FDA，欧盟CE，中国CFDA等以及市场咨询服务。

我们帮助中国医疗器械企业提供从产品设计开发过程中的合规，产品的国际注册，国际专业医械市场容量分析，健康法规咨询，市场同业竞争分析，国际医疗运营咨询等。通过设立在美国迈阿密和中国北京的办公室，为客户提供快速的本地化服务，快捷的与监管部门的沟通从而达到更加快速的取得产品注册，帮助进入目标市场。

我们作为美国医疗器械法规学会的成员(Regulatory Affairs Professional Society, RAPS)，及时了解国际医械监管的最新要求。我们的咨询师均有丰富的实战经验或坚实的理论背景。自从2009年成立以来，我们服务过的的客户包括大型耐用医疗设备生产商，大型医药集团医疗器械部，医疗设备生产商等。

P&L SCIENTIFIC is a professional medical device regulatory compliance and market consultancy company. We mainly engaged in medical devices, in vitro diagnostic reagent products in the international registration, including the U.S. FDA, EU CE, China CFDA etc., and market advisory services.

We assist medical device companies from product design and development process, international registration, market capacity analysis, advisory of the international health regulations, analysis of competition. We have offices both in Miami , the U.S. and Beijing, China , to provide fast local service and communication with the regulatory authorities so as to achieve timelier product registration.

We, as a member of the Regulatory Affairs Professional Society, RAPS, to keep informed of the latest international regulatory requirements. Our existing consultants have either a rich industry experience or a solid theoretical background. Since 2009, we have served numerous clients include a major durable medical equipment manufacturer, medical equipment division of a large healthcare group, and other medical equipment manufacturers.

为什么选择百力

• 中美两地均有办公室-更快的与监管机构的沟通

• 咨询师具有丰富的医疗器械领域背景-我们的服务更有帮助

• 美国医疗法规学会成员-更快的获得最新监管要求

Why choose P & L?

• Both offices in China and USA- faster communications between you and regulatory authorities!
• Member of Regulatory Affairs Professional Society (RAPS, USA)- rest assured!
• Solid medical industry background-faster to get your products cleared!