We are offering the CH-REP (Swiss Authorized Representative) for In our latest episode, we simplify essential concepts that are crucial for anyone involved in medical device development. Here's a
Are you in the medical device industry and aiming for top-notch quality management? Then you need to know about ISO 13485 An authorised representative based in the EU is required for any medical device which does not have an EU based manufacturer.
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Under the newly established regulations, Article 51 of the #Medical #Device Ordinance (#MedDO) and Article 44 of the In Vitro Medical Device & Accessory Under EU MDR
Webpage: The new Medical Device Regulation EU MDR 2017/745 and IVDR Learn the Good Document Practices for Medical Devices Medical Device News - December 2022 update
Prepare your Transition from Class I to Class Ir with Tautvydas In-Country Representation for Medical Devices and IVDs in the EU, UK, and Switzerland Marketing medical devices in the EU can be a challenge. This article explains the different regulatory bodies, their roles in the market
Regulatory Pathway: Reach the US market [Class II 510k exempt] European Authorized Representative for Medical Device and IVD
What is the role of a PRRC within a Manufacturer & an Authorized Representative Authorised representatives, importers and distributors under the MDR The #MDR can be a daunting task to undertake on your own. Make sure you avoid any confusion and get all the information you
Swiss authorised representative (CH-REP) Notified Bodies reassessment
Distributor role within MDR and IVDR with Nicolaj Nitzsch The EU MDR is planning to be really challenging for Class I reusable Surgical Instruments as they will need to move to Class Ir. In MedEnvoy Provides Experienced, Authorized In-Country Representation for Medical Devices and IVDs in the EU, UK, and
UK Responsible Person and Brexit Consulting for Medical Devices European Authorized Representative What is an EC REP? Why do you need one? How do you appoint one? Did you know it is
HOT TOPICS Europe Common specifications for the groups of products without an intended medical purpose listed in Annex XVI What is a European Authorized Representative? Why do you need one? What are their responsibilities and can I sell my medical
Risk Management is a discipline of its own within the Medical Device field. In ISO 13485, EU MDR 2017/745, IVDR 2017/746, EU Technical File for Medical Devices
Vigilance Reporting is a process that you should have but that you don't want to use. In fact not having any vigilance reporting is a Non-EU Manufacturers: Appointing an Authorized Representative (EC-REP) for Medical Devices and IVD`s
A Technical File is proof that a medical device complies with the essential safety and health requirements set down by the relevant What are the acceptance criteria for clinical evaluation ? Navigating Switzerland's Medical Device Regulations: The Role of Swiss Authorized Representatives
In this video Monir El Azzouzi is introducing one of the best eQMS SmartEye and will show you all the different modules. This episode of the podcast is about the TEAM-PRRC event in Brussels that happened November 3-4, 2022. This sequence was
Do you need a Swiss Authorised Representative and Importer? [Medical Devices] European Authorized Representative European Authorized Representative for Medical Devices | Exportia France
European Authorized Representative - Explanation from our expert Max MDR - Article 11 - Authorised representative - Medical Device ToEX becomes CH-REP
ISO 13485 Authorized Representative l The Learning Reservoir Veranex brings decades of regulatory expertise as your EU Authorized Representative for medical devices, understanding the complex requirements of MDR 2017/745
Are you a manufacturer of medical devices? Are you looking for help in entering European markets? Find out how we can help in You are required to appoint an Authorized Representative (also referred to as an EC REP or AR) to represent your company to European authorities. Medical Device: All about the role of PRRC [Team PRRC event]
Discover how MedNet EC-REP GmbH simplifies EU compliance for medical device and IVD manufacturers with authorized This is really a difficult situation if your company goes bankrupt. But now the idea is what to do regarding the products that are still What is the role of PRRC within the manufacturer and authorized representative?
Any reference in this Regulation to the competent authority of the Member State in which the manufacturer has its registered place of business How to get MDSAP Certified for your Medical Devices? ISO 13485 Explained: Key Documentation Requirements for Medical Devices
Key Roles in Medical Devices: Who's Who in Manufacturing, In this episode, Lucas Pianegonda will help us to select the right material for your medical device and also answer questions that Defining European Authorized Representative (EC REP)
In this episode of MedTech Global Insights, we explore one of the most critical decisions for non-EU device manufacturers: Why Risk Management is critical to Medical Device Development?
Welcome to our comprehensive guide on the pivotal role of an EU Authorized Representative in the realm of medical devices. Our knowledgeable colleagues Annemieke and Emile teamed up to create a concise and engaging video presentation on the
EU Authorized Representative (EU-REP) for Medical Devices New Video: EU MDR Series! We're diving into Article 2 of the EU MDR 2017/745, covering the key definitions Under the European Directive for Medical Devices (EU 2017/745), a manufacturer of a device, which is not established in a
How to select the best plastic for your Medical Device? ๐๐๐ฒ ๐๐จ๐ฅ๐๐ฌ ๐ข๐ง ๐๐๐๐ข๐๐๐ฅ ๐๐๐ฏ๐ข๐๐๐ฌ: ๐๐ก๐จ'๐ฌ ๐๐ก๐จ ๐ข๐ง ๐๐๐ง๐ฎ๐๐๐๐ญ๐ฎ๐ซ๐ข๐ง๐ , ๐๐๐๐ฎ๐ซ๐๐ข๐ฌ๐ก๐ข๐ง๐ , ๐๐ง๐ ๐๐๐ฉ๐ซ๐๐ฌ๐๐ง๐ญ๐๐ญ๐ข๐จ๐ง Importers and authorized representatives are among the economic operators defined in the MDR/IVDR, each with their respective
What is a European Authorized Representative or EC Rep or CE Representative? (EU Medical Device Regulation MDR Thinking of selling medical devices in Saudi Arabia? Here's what every medical device manufacturer needs to know about
Switzerland: Europe's Precision Med-Tech Powerhouse Home to nearly 9 million people and a world-renowned life-sciences Medical devices. Unlike medicinal products, medical devices do not undergo an official authorisation procedure. Swissmedic's focus in the area of medical Why Medical Device and IVD Manufacturers Need a Regulatory Importer
One of the best eQMS for Medical Devices Swiss Authorized Representative for selling medical devices | Q&A with Martin Epper from epmodex Medical Devices: access to EU and UK market
Sterilization for medical devices is a critical topic. Now when you are developing your Medical Device, you should start by asking EU Market Access Secrets: Selecting the Best Medical Device Authorized Representative with Pure G
What if your Medical Device company goes Bankrupt? In this video, we explain what an Authorized Representative is as per ISO 13485:2016, the international standard for quality
Manufacturers with no local presence in the UK must now appoint a UK Responsible Person (UKRP). Your UKRP is responsible for managing your device registration How to choose your Sterilization method for Medical Devices?
During this LinkedIn Live session, I have invited Erik Vollebregt, a lawyer at Axon Lawyer to help us understand the situation of This is an excerpt from the course "The Medical Device Regulation (EU) 2017/745" which is available at: You maybe ask yourself how to get to distribute your Medical Device in the US? Then listen to the story of MysteryVibe with their
๐๐ง๐๐๐ซ๐ฌ๐ญ๐๐ง๐๐ข๐ง๐ ๐๐๐ฒ ๐๐๐ซ๐ฆ๐ฌ ๐ข๐ง ๐๐ฅ๐ข๐ง๐ข๐๐๐ฅ ๐๐ง๐ฏ๐๐ฌ๐ญ๐ข๐ ๐๐ญ๐ข๐จ๐ง๐ฌ! We all are afraid of one thing. It is to see our Clinical Evaluation rejected by a Notified Body. Why? Because apparently EU MDR is Check out this video for a nice introduction to the many important factors to consider in selecting who shall serve
Within this video you will see 4 interviews on the PRRC role. First one with Piero Costa where we will talk about the role of a Since May 26th, 2021 Switzerland is now considered as non-EU country for Medical Devices. So to sell your products in Martin from epmodex summarizes the key points around the role of the Swiss Autohorized Representative.
3 Common mistakes about the Medical Device Regulation! Adam Isaacs Rae: Key Standards for Sterilized Products Navigating Software Validation in Medical Devices
The process of appointing a European Authorized Representative for Medical Device and Invitro Diagnostic Device. Authorised Representatives โ Regulation (EU) 2017/745 (EU MDR) Swissmedic Switzerland Medical Device Registration by Pure Global
EU Authorized Representative Medical Device | Veranex iCRO An EU authorized representative is mandatory for all non-EU manufacturers and is equally liable with the manufacturer. The EU REP performs a Prepare your transition from Class I to Class Ir!
Authorised Representatives, Importers and Distributors - Public Health Podcast page: โป Medboard platform: โป MEDBOARD What you should know about Vigilance Reporting for Medical Devices?
Within this episode I will explain to you how you can be MDSAP certified for your Medical Devices. The agenda for this episode is The Regulations also introduce a system of unique device identifiers (UDIs) to allow the identification of medical devices and facilitate their traceability. In Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working
What is the EU Authorised Representative service? what is the UK's strategy to regulate device? What is a European Authorized Representative (EU MDR 2017/745)
Potential risks detection in PMS Competent Authority, Notified Body, Authorized Representative
European Authorized Representative for Medical Device Companies FAQ Medical Device Economic Operators ? (EU MDR and IVDR)