医疗器械监管咨询与市场准入情况

遍布世界各地超过2,800家医疗器械和IVD公司依赖于Emergo集团的服务。

WEBINAR: Understanding the US FDA De Novo Process

In our May 24th webinar, we will discuss the benefits and criteria of the US FDA de novo program and how qualifying device companies can pursue this pathway to the US market.

Meet the Emergo team at Hospitalar

Book an appointment with us at the show to discuss your questions about compliance in Brazil or other markets worldwide.

Get the latest regulatory news delivered to your inbox

We stay on top of device regulatory changes so you don’t have to. Subscribe to our newsletter for weekly updates on market news, white papers, webinars, and more.

The US FDA 510(k) Clearance Process

This short video shows you what it takes to prepare and submit a medical device 510(k) to the US FDA.

Mapping Cybersecurity Standards to FDA Guidance

Learn about medical device cybersecurity and how the UL 2900 standards correspond to FDA guidance in this one-hour recorded webinar.

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Emergo集团拥有能够帮助您在全球范围内发展业务的医疗器械顾问专家。

Emergo集团是帮助您进入全世界最大以及发展最快的市场的单一资源。 我们在超过20个不同国家拥有办事处,可以提供专业的服务,帮助您研究新市场、遵守国家医疗器械与IVD规定、管控您的医疗器械的注册登记并与高质量分销商合作。 了解我们可以如何帮助您进一步发展。

  • 临床咨询
    临床前期策略、临床评估报告和后期市场研究。
  • 医疗器械注册登记
    点击查看我们在全球20多个不同市场为上千项医疗器械进行注册登记的专业经验
  • 质量管理体系(QMS)合规性
    针对ISO 13485、美国食品药品管理局(FDA)质量体系法规(QSR)及其他质量管理体系的实施与内部审计。

参见Emergo集团如何就全世界的医疗器械监管问题向来自{{country}}的公司提供帮助。