?? Exciting News for Medical Device Professionals! ?? We are thrilled to share that we have compiled a comprehensive list of 355 ISO standards specifically related to Medical Devices. This curated list is designed to save you valuable time by consolidating essential standards in one convenient place. Share it across your network and spread the knowledge!! ?? Categories Include: General Standards, Medical Device-Specific Standards, Implanted Device Standards, Software Standards, Dentistry ?? Whether you're in RA, QA, or any other area of the medical device industry, this list is a valuable resource to ensure compliance. By having these standards, you can focus more on innovation and less on searching for the right standards. Stay ahead in the industry and ensure your products meet the highest standards of safety and efficacy. Feel free to reach out if you have any questions or need further assistance and hit "FOLLOW" button for more informations. #MedicalDevices #ISOStandards #RegulatoryAffairs #QualityAssurance #HealthcareInnovation #Compliance #MedicalDeviceStandards #iso #usfda #medtech #pharma #innovation #development #technology
Global MedRegs
科技、信息和网络
Simplify Your Regulatory Journey Across International?Markets Follow for more Insights on Medevice Regulatory Affairs.
关于我们
Our mission is to facilitate global market access for medical device manufacturers by offering a user-friendly interface that navigates through country-specific regulatory requirements, ultimately saving precious time and costs. Navigating the global landscape of medical device regulations can be daunting due to various challenges. Regulatory authority websites are often not user-friendly, making it difficult to find specific information for a particular country. Users may need to search multiple sources, which can be time-consuming and challenging. Additionally, language barriers on some websites, as they are published in the local language, can impede access to critical information To address these challenges, we have developed a comprehensive website that compiles regulatory requirements for 106 countries, organized into four main regions: Asia-Pacific, Africa, America, and Europe. Our platform assists manufacturers or users by providing details about regulatory authorities, country websites, medical device and IVD classifications, regulations, registration processes, and timelines, authorized representative requirements, language needs for labeling, database, adverse event reporting form and additional information. We have also provided hyperlinks to country websites, regulations, and registration procedures, simplifying navigation and ensuring users can easily access relevant information across all countries.
- 网站
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https://www.globalmedregs.com/
Global MedRegs的外部链接
- 所属行业
- 科技、信息和网络
- 规模
- 2-10 人
- 总部
- Boston
- 类型
- 私人持股
- 创立
- 2024
- 领域
- medical device、regulatory affairs、global regulatory affairs、regulatory requirements、regulations、device classifications、compliance、regulatory authority、organization、medtech、medical equipment、registration、database、labeling、countries、international market、regulatory agency、standards、guidance和guidelines
地点
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主要
US,Boston
Global MedRegs员工
动态
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We are excited to share a quick demonstration of Global MedRegs in action! ???? Our platform is designed to streamline access to global regulatory information for medical devices, empowering manufacturers with the tools they need to navigate complex international markets. The video highlights how users can effortlessly explore regulatory requirements across multiple countries through our user-friendly interface and access vital information. This demonstration offers valuable insight into how Global MedRegs simplifies the regulatory journey, saving time and reducing complexity for medical device manufacturers. Let us know what you think, and feel free to reach out for more details! #GlobalMedRegs #MedicalDevices #RegulatoryAffairs #MedTech #Compliance
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This image is a world map showing the Regulatory Density for Medical Devices across various countries, sourced from C2P by Compliance & Risks. The map uses different shades of green to indicate the volume of medical device regulations in each country: 1. Countries with Maximum Volume of Regulations (dark green): These are countries with the most extensive and complex medical device regulatory frameworks. Based on the map, countries like Brazil, the United States, and China are shown to have high regulatory density, indicating stringent and comprehensive regulations. 2. Countries with Moderate Volume of Regulations (medium green): These nations have a well-developed but not as dense regulatory framework as the first group. Examples include Australia, parts of Europe, and India. 3. Countries with Lesser Volume of Regulations(light green): These countries have fewer regulations in place for medical devices. This could be due to developing regulatory systems or smaller medical device markets. Parts of Africa and the Middle East fall into this category. This visualization helps highlight global differences in regulatory environments, essential for companies and professionals navigating international medical device compliance. #world #medicaldevice #regulations #iso #medtech #regulatory #risk #marketing #standards #healthcare #device #compliance
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Stay informed about global regulatory requirements for medical devices by following our page. Every Monday, we will share the regulatory information for a different country. Join us in spreading knowledge and enhancing compliance awareness across your professional network. #regulatoryaffairs #global #regulations #standards #Labels #language? #classification #medicaldevices #ivd #iso #medtech #healthcare? #innovation #raps #biomedical
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Stay informed about global regulatory requirements for medical devices by following our page. Every Monday, we will share the regulatory information for a different country. Join us in spreading knowledge and enhancing compliance awareness across your professional network. #regulatoryaffairs #global #regulations #standards #Labels #language #classification #medicaldevices #ivd #iso #medtech #healthcare #innovation #raps #biomedical
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Stay informed about global regulatory requirements for medical devices by following our page. Every Monday, we will share the regulatory information for a different country. Join us in spreading knowledge and enhancing compliance awareness across your professional network. #iceland #regulatoryaffairs #global #regulations #standards #Labels #language #classification #medicaldevices #ivd #iso #medtech #healthcare #innovation #raps #biomedical
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Stay informed about global regulatory requirements for medical devices by following our page. Every Monday, we will share the regulatory information for a different country. Join us in spreading knowledge and enhancing compliance awareness across your professional network. #portugal #regulatoryaffairs #global #regulations #standards #Labels #language #classification #medicaldevices #ivd #iso #medtech #healthcare #innovation #raps #biomedical
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Stay informed about global regulatory requirements for medical devices by following our page. Every Monday, we will share the regulatory information for a different country. Join us in spreading knowledge and enhancing compliance awareness across your professional network. #argentina #regulatoryaffairs #global #regulations #standards #Labels #language #classification #medicaldevices #ivd #iso #medtech #healthcare #innovation #raps #biomedical
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A lot of people are perplexed by the distinction between FSCA and FSN. This article is to understand the difference between FSCA and FSN?and how the manufacturer has to take action during FSCA and FSN. Spread this information among your network, and stay tuned for more information concerning the regulatory framework for medical devices. #fscn #fsn #risk #safety #device #fda #postmarket #pms #regulatory #learning
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Stay informed about global regulatory requirements for medical devices by following our page. Every Monday, we will share the regulatory information for a different country. Join us in spreading knowledge and enhancing compliance awareness across your professional network. #southafrica #regulatoryaffairs #global #regulations #standards #Labels #language #classification #medicaldevices #ivd #iso #medtech #healthcare #innovation #raps #biomedical