Industry Focus

The healthcare industry is changing and we have the breadth of expertise to help you evolve with it.

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Services

Comprehensive service offerings at every point in the product life cycle.

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RAMS®

A platform of digital products to improve, simplify and automate RA/QA activities

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OPUS™

Emergo by UL's new human factors tool - provides training, tools, and resources.

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Software

Our software tools offer digital regulatory monitoring for medical device compliance and access to human factors engineering tools.

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News

The latest industry news and insights from our global team.

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RADAR : Market Access Newsletter

Stay informed with the most read RA/QA medical device newsletter.

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TalkingPoints : Human Factors Newsletter

TalkingPoints is a round-up of news, insights, and resources about human factors and usability for medical devices, IVDs, combination products, and more.

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Our global consulting team works from 20+ offices on six continents.

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Medical Device Market Access Consulting

医疗器械市场准入

自 1997 年以来，Emergo by UL 一直在为医疗器械和体外诊断器械公司提供合规和市场准入服务。

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医疗器械与体外诊断器械（IVD）合规咨询

我们的咨询团队已经为我们的客户提供了数千个医疗器械和体外诊断器械项目的支持。

  • 我们协助医疗器械和体外诊断器械公司在 20 多个国家/地区注册他们的产品，包括澳大利亚、巴西、欧洲、日本和美国。
  • 全球超过 150 名顾问
  • 多样化的产品体验和专注的专业领域，助力解决您棘手的挑战

医疗器械市场准入服务

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合规事务咨询

借助我们的专业知识应对复杂的合规挑战。我们可以协助您制定合规和质量管理体系策略，将您的产品推向全球成熟市场和新兴市场。

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医疗器械注册

我们凭借多年实践经验，助力我们的客户尽可能高效地将产品推向市场。我们可以协助编制文件、递交申请，并管理各项医疗器械注册事宜。

 

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当地代表

数以千计的医疗器械公司选择 Emergo by UL 担任其独立的当地代表，进而确保对医疗器械注册的有效管控。

 

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上市后监管

我们根据医疗器械整个生命周期内的安全性和有效性，提供上市后合规解决方案、不良事件报告及全球警戒支持服务。
 

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软件开发咨询

利用我们的专业知识，助您实现法规合规，并在全球市场成功销售您的医疗器械。

 

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全球监管并购（M&A）服务

我们的专业知识可支持将监管合规高效整合到您的并购（M&A）策略中，促进平稳过渡，助力交易价值的最大化。

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RAMS：法规事务管理平台

推出法规事务管理平台（RAMS）：一款助力全球市场准入的数字平台。

凭借 20 多年的合规经验，我们开发了一款数字平台，助力提供合规资讯、研究支持等。

看看 RAMS 能为您做些什么！

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全球医疗器械市场准入咨询
我们助力客户拓展在全球主要医疗器械市场的覆盖范围。请按地区查看我们提供的服务。
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European Union

We are experts in European medical device and IVD compliance. We'll help you navigate regulatory changes in the EU.
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United States

From 510(k) consulting to QSR implementation, we can help you obtain FDA clearance for your medical device.
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Japan

Our consulting team in Tokyo delivers local expertise and support for companies seeking PMDA approval in Japan.
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Brazil

Gain access to one of Latin America's biggest medical device markets with the help of our Brazil-based team.
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Mexico

We provide submission preparation and classification consulting to help companies navigate COFEPRIS requirements.
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Global Services

We can help you design and execute a regulatory strategy across major and emerging medical device markets.
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需要欧盟 MDR 方面的帮助？

访问我们的欧盟医疗器械法规（MDR）资源中心，认识我们的 MDR 团队并获取相关免费资源。

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医疗器械市场准入相关新闻

从我们的市场准入专家那里获取更新的行业见解。

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