NQA’s Post

📑 We have already shared the news that we had been successfully certified to ISO 13485:2016, the international standard for quality management systems for medical devices. Today we'd like to show off the paper version of this document. We worked hard to achieve this certification, and we're proud to have met the rigorous requirements. We believe that this certification will help us to improve our products and services and to better serve our customers. 🔎 Read more in our blog post: https://lnkd.in/d3rTjmEZ #ISO13485 #MedicalDevices #RegulatoryCompliance

Here are the (surprising) results of last week’s survey…+ a free gift. 🎁 I asked you whether it is mandatory to validate test methods in #MedTech. ✅ 78 % said it is mandatory ❌ 7 % said that test method validation is not a mandatory requirement in MedTech, and ❌ 15 % said it depends I’m surprised by this result because I did not expect that so many people would know that test method validation is a mandatory requirement as per current regulations. It’s surprising because, in my opinion, it is not so clear that it is actually mandatory. MDR 2017/745, for example, does not directly mention test method validation. Standards like ISO 11607 or ISO 11608 require TMV, just like the MDSAP. Most important regulations and standards ask for a test method validation with a very good reason: 👉 When you ensure your test method is valid, you decrease the risk of defective medical devices on the market significantly. Whether regulations ask for it or not, not only from a data integrity point of view, you should ALWAYS do a test method validation. To ensure your test method validation is compliant with MedTech regulations and standards, I invite you to use my TMV compliance checklist. Just send me a private message, and I’ll share it with you. 💪 #medizintechnik #medicaldevices #testmethod #validation

"𝐃𝐨𝐧'𝐭 𝐆𝐞𝐭 𝐂𝐚𝐮𝐠𝐡𝐭 𝐎𝐟𝐟 𝐆𝐮𝐚𝐫𝐝: 𝐇𝐨𝐰 𝐭𝐨 𝐌𝐞𝐞𝐭 𝐭𝐡𝐞 𝐄𝐔'𝐬 2024 𝐌𝐃𝐑 𝐃𝐞𝐚𝐝𝐥𝐢𝐧𝐞𝐬" ✍️ Authored by RQM+ experts Amie Smirthwaite, PhD, FRAPS & Jaishankar Kutty, Ph.D. 📣 In case you missed our essential guide for navigating the EU's Medical Device Regulation (MDR) deadlines. With 2024 fast approaching, it's crucial to stay ahead of the curve! (🔗 to full blog in comments). 🔑 Key Insights: - Understand the importance of meeting interim deadlines to avoid a last-minute rush. - Discover strategic steps for ensuring your MDR application is accepted. - Learn how to avoid common pitfalls in your Notified Body (NB) applications. - Ensure your Quality Management System (QMS) is MDR compliant. - Grasp additional requirements for manufacturers and economic operators under MDR. 👉 Read this blog to equip yourself with the knowledge and strategies needed for a smooth transition to MDR compliance (link in comments!) #RQMplus #MedTech #eumdr

🕒 Episode 10: What are the Different Conformity Assessment Routes? - A 60-Second Special! Welcome back to "Medical Device Regulation in 30 Seconds"! Today, we're taking a minute instead to cover a topic suggested by Sarai Pahla: conformity assessment routes. Let's dive in! To obtain the CE mark, there are several key routes, each suited to different device classes and manufacturer preferences. Here’s a clear breakdown: Self-Certification (Annex IV): This route is exclusively for Class I devices, offering a straightforward path without involving a Notified Body. 📄 Full Quality Management System (Annex IX): The most common choice for manufacturers, requiring a quality management system. Given that the MDR already demands a QMS following article 10, this is a practical step. 🔍 Type-Examination (Annex X): Aimed at high-risk devices, combining this with Annex XI is necessary. The main idea is that a Notified Body makes a complete check of a medical device sample. It's particularly relevant for complex devices produced in smaller quantities. 🛠️ Product Conformity Verification (Annex XI): This can be split into Part A for Production Quality Assurance and Part B for Product Verification, allowing manufacturers to choose based on their specific situation. Here, parts of a QMS are checked by the Notified Body ✔️ Custom Made Devices (Annex XIII): A distinct route for custom-made devices, differing significantly from the others and catering to unique requirements. ✂️ Wondering which route fits your product? Article 52 of the MDR details all possible combinations for every class of medical device, providing a comprehensive guide. Have another topic you're curious about? Leave a comment or send me a DM. 💬 Don’t miss out on future insights, hit the bell on my profile. 🔔 Creatives by Monica Huonder #mdr #eumdr #medicaldevice #medicaldevices #regulatoryaffairs

At MedQtech, we don’t just follow ISO standards – we’re part of the conversations that shape them. Our very own Therese and Sofie are members of the ISO Standards Committee TK355 at Swedish Standards Institute (SIS). This keeps them connected to the latest developments and upcoming changes in the world of medical device regulations. When you partner with MedQtech, you can trust that you're working with a team of industry experts who can inform you of upcoming changes and how to best interpret them. Contact us to find out more about the insights and guidance we can provide on your compliance journey >> https://loom.ly/JWIfRHo #eQMS #medicaldevices #medicaldeviceregulation

In follow up to ISO/TC 210 plenary discussions in December 2022 regarding preparatory work on items for revision of ISO 13485:2016, an ISO/TC 210 ad-hoc group has developed a survey for the medical device community about the standard The intent of this survey is to gather stakeholder feedback on the existing use of the standard for regulatory purposes. With the current regulatory environment for medical devices, the survey aims to find the benefits and the negative impact and look at any revisions Please click the link below to take the survey and of course share any thoughts of your own in the comments! #medicaldevice #ISO13485 https://lnkd.in/eRid9zhx

💡In the ever-evolving field of medical device regulation, the Medical Device Regulation (MDR) has introduced significant changes to enhance transparency, safety, and traceability. One crucial aspect of MDR compliance is Trend Reporting, a mechanism designed to identify and address emerging issues related to medical devices. 💊📈 🔍Please visit our website for our new article on MDR Trend Reporting 👉https://lnkd.in/dNE669Ti. 💡This article delves into the intricacies of MDR Trend Reporting, exploring its importance, requirements, and the impact it has on the medical device industry. #mdr #trend #reporting #euregulations #regulatory #compliance #medicaldevices

🔹 2023 Harmonized Standards Implementation for MDR In 2023, the European Commission published the Commission Implementing Decision (EU) 2023/1410 of 4 July 2023 amending Implementing Decision (EU) 2021/1182. From this, 2 new #HarmonizedStandards have been added to the list: 🔹 EN ISO 25424:2019 Sterilisation of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 25424:2018); EN ISO 25424:2019/A1:2022 🔹 EN ISO 10993-10:2023 Biological evaluation of medical devices – Part 10: Tests for skin sensitisation (ISO 10993-10:2021) #medtechadvancements #medicaldevice #AuthorisedRepresentative #MDR

Attention packaging professionals in the realm of terminally sterilized medical devices! Exciting updates have arrived with the revised BS EN ISO 11607-1:2019+A1:2023, putting a stronger spotlight on risk management for enhanced EU MDR compliance and advanced procedural standards. Equally significant, the amended BS EN ISO 11607-2:2019+A1:2023 empowers those involved in process development or validation, emphasizing robust risk management to elevate practices and align with EU MDR requirements. Delve into these pivotal updates shaping the landscape of medical device packaging for top-tier compliance and innovation! Find more about BS EN ISO 11607-2:2019+A1:2023 here: https://bit.ly/3RgGKPT Discover BS EN ISO 11607-1:2019+A1:2023. Click now: https://bit.ly/3G7A3ZT #BSIStandards #IBSENSO11607 #MedicalDeviceStandards #MedicalDevices

The European Commission has just published more results of the Notified Bodies Survey on certifications and applications (8th NB survey). The aim of the study is to support monitoring and analyzing the availability of medical devices on the EU market in the context of the implementation of MDR/IVDR from the perspectives of key stakeholders. These survey results are also compared with previous survey data. These results contain dates that are interesting for manufacturers. For example: - How long is the average time frame between application lodged and written agreement signed? - What are the reasons for a refusal of a MDR/IVDR application? - How complete are the submissions? (SPOILER: We think these numbers are still way too high) - How much time does it take in average to get a QMS/QMS+Product Certificate? For these and more information have a look at the study. Source of the study: https://lnkd.in/e3Hm85mb Results of the previous surveys can be found in the dashboard: https://lnkd.in/dpB--Up8 #mdr #ivdr #notified body #europeancommission #astracon