?? ???????? ?????????????????? ???????? ?????? & ????????! Need ready-to-use agreements that save you time and ensure compliance? ?? EMD offers updated templates for: ? Distributors ? Importers ? Suppliers ? PRRC - Manufacturers ? EU Authorized Representatives All aligned with MDR & IVDR requirements! Perfect for medical device professionals who want clarity, speed, and peace of mind. ?? Need more agreements? Contact us at: [email protected] #MedicalDevice #MDR #IVDR #RegulatoryAffairs #Compliance #EasyMedicalDevice #MedTech #Templates
Easy Medical Device
科技、信息和网络
basel，Basel Stadt 15,492 位关注者
Consulting Agency. Help you place your Compliant Medical Device on the market
关于我们
Easy Medical Device is a company that will support you to place your Medical Device on the market. With its network, the company is capable of finding you the right support you need to execute your tasks. If you have a project to develop or a problem to solve in terms of Quality and Regulatory Affairs, Easy Medical Device is your solution. We help companies that are bringing new devices on the market or companies that just need an upgrade of their system. We can also find you the right partners like European Authorized Representative or consulting firm in different countries. We can help you with the EU MDR or IVDR, the FDA QSR, the ANVISA, Health Canada... If you look to be ISO 13485 certified or even MDSAP certified then we are your partners. Easy Medical Device does have a set of tools that can also help you if you want to perform your compliance alone. Visit our shop at https://school.easymedicaldevice.com/shop to see what is available for you. Don't hesitate to contact us if you have any questions.
- 网站
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https://easymedicaldevice.com
Easy Medical Device的外部链接
- 所属行业
- 科技、信息和网络
- 规模
- 2-10 人
- 总部
- basel，Basel Stadt
- 类型
- 私人持股
- 创立
- 2018
- 领域
- Medical devices、Regulatory affairs、quality management、medical device、ISO 13485、ISO 14971、CAPA、Audits、Internal Audit、SaMD、Design Control、Compliance、European Regulation、ce marking、MDSAP、fda、EU MDR、mdr 2017/745、Medical Device Regulation、Consulting 、consulting firm、Consultant、European Authorized Representative、Medtech industry、Podcast、Blog、Conference和Speaker
地点
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主要
获取路线
bernouillstrasse 20
CH，Basel Stadt，basel，4056
Easy Medical Device员工
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Monir El Azzouzi
Founder & CEO at Easy Medical Device | Consulting Firm | Podcast Host
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Hisham Al-Qazaz (TQM, MDQMS, CRCM, MBA)
Compliance & Regulatory Affairs Manager for Kimal
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Mateus Lima
Regulatory Affairs | Quality Assurance | Medical Device Specialist | ISO 13485 | ISO 14971 | EU.MDR 17.745
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Hanieh Malakooti
Freelance Quality and Regulatory Affairs (QRA) Consultant for Medical Devices in EU and FDA
动态
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??? ?????????????? ?????????????? ??? In this episode, Tibor Zechmeister will challenge us on what we would answer if the Notified Body asks if our software is validated. CSV or Computer System Validation will become one of the major topics. So stay tuned. Share this with your contacts if you know someone that would benefit from it. Check this here https://lnkd.in/eJe2TfAJ #medicaldevice #easymedicaldevice #regulatoryaffairs #podcast #startups ?
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?? ?????? 13485 ???????????????? ???? ?????????????? – ?????????? ?????? ?????????????? ????! ?? Join us in ?????????? ???? ?????????? 9-10 for a???????????-???? ?????? 13485 certification training that will take you from theory to real-world application. ?? ???? Led by Monir El Azzouzi, CEO of Easy Medical Device and expert with 19+ years in ?????????????? & ???????????????????? ??????????????. ? Practical insights ? Real case studies ? Perfect for professionals aiming to implement or optimize ISO 13485 in their company ?? ????????????????: ??????????, ?????????????? ?? ??????????: ?????????? 9-10 ?? ????????????????: ???????????? ???? ?? Don’t miss this opportunity to level up your skills and network with other industry professionals. ?? Register now and secure your seat before it’s too late! ?? https://lnkd.in/em52sfKP #ISO13485 #MedicalDevices #QualityManagement #Training #Morocco #EasyMedicalDevice #MonirElAzzouzi #RegulatoryAffairs #QualityAssurance #MedTech #Rabat
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?? ?????? ???? ???????? ?? ?????? ??????????????????, ??????????? Well… 187 pages, 10 annexes, and 3 coffee refills later, here we are ????? If you know, you know. Shoutout to all the regulatory & QA warriors making it through MDR one section at a time! ?? #MedicalDevices #MDR #RegulatoryAffairs #QualityManagement #MedTechHumor #ComplianceLife #EasyMedicalDevice
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- Stop Ignoring Human Error in Quality Management Systems! For full episode check: https://lnkd.in/eFFuWDB4 Monir El Azzouzi Darrin Carlson, RAC-Devices, PMP #easymedicaldevice #medicaldevice #regulatorycompliance
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?????? ???????? ????????????????: ???????? ???????????? ???????????????????? ?????? 2025 ?? The MDCG has released an important revision regarding the update procedures of the European Medical Device Nomenclature (EMDN). ? Annual updates now follow a 4-phase process, from submission to MDCG endorsement ? A new ad-hoc procedure allows expedited reviews – but only for competent authorities and notified bodies ?? All changes will be reflected in EUDAMED and the EMDN browser At EMD, we stay ahead of regulatory changes to support medical device companies with compliance and clarity. ?? Download the full MDCG 2024-2 Rev.1 update and understand what’s new. https://lnkd.in/d83VWt6A
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-Mastering FDA Compliance_ The Pareto Approach Explained For full episode check: https://lnkd.in/eFFuWDB4 Monir El Azzouzi Darrin Carlson, RAC-Devices, PMP #easymedicaldevice #medicaldevice #regulatorycompliance
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?? ?????????? ???? ????????????????????? Which path should be prioritized for evaluation? On one side, Audits focus on continuous improvement and internal compliance. On the other, Inspections enforce safety and legal requirements by external authorities. ?? Understanding the difference is key to staying compliant and proactive. Which process do you think drives more long-term value? Let's discuss ?? #Audit #Inspection #QualityManagement #Compliance #RegulatoryAffairs #MedicalDevices #ISO13485 #GMP #CAPA #QualityAssurance
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?? ?????????????????????????? ??????: ?????????????????? ?????? ?????????????? ???????????? ???????????????????? ?? Navigating the complexities of the UDI (Unique Device Identification) system is crucial for compliance in the medical device industry. Our latest blog post dives deep into the core components of UDI and how they’re vital for tracking and monitoring medical devices. From UDI-DI to AIDC and UDI-PI, we cover the essential elements that manufacturers, regulators, and health professionals need to know. ?? ???????? ??????’???? ??????????: The key elements of UDI and its regulation Understanding the roles of UDI-DI, UDI-PI, and other identifiers How AIDC and QR codes contribute to device traceability Stay ahead in the industry and ensure your compliance with UDI standards. ?? Read the full blog here : https://lnkd.in/eKVZWhf #MedicalDevices #UDI #Compliance #HealthTech #Regulations #Innovation #EasyMedicalDevice
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?? ?????????? ????. ????????????????????: ?????????? ????????????????? ??????’???? ?????? ?????????? In the medical device world, compliance isn’t just a checkbox—it’s survival. Yet many still mix up audits and inspections like they're twins… Spoiler alert: They’re not. ???♀? ?? ???? ?????? ???????????? ???????? ?????????????? ???????????? ????????????????????, ???? ?????????? ???? ?????? ????????: ? What’s the real difference between an audit and an inspection ? Who conducts them, when, and why ? How to get your team audit- and inspection-ready ? What happens if you’re NOT prepared (hint: it’s not pretty) ?? Plus, we’ve got expert insights from names like Dr. Vikas Ghattargi, @Jennie Clark , and Rajha Rajamurthi on how to navigate both processes without panic. ??? Don’t miss this week’s podcast on the Top 3 FDA Inspection Issues ?? Read our blog on preparing for your Notified Body audit ?? Download tools to help with MDSAP audits and EMDN classification ??? Compliance is a process. Let us help you master it. ?? Read the full newsletter and share your biggest audit/inspection horror story in the comments! #MedicalDevices #Compliance #Audits #Inspections #QualityAssurance #MDR #IVDR #ISO13485 #EasyMedicalDevice #Newsletter