K3-Innovations, Inc.’s Post

New Amendment correlating between GSPR and EN 60601-1:2006+A1+A12+A2+A13:2024. I can see a new checklist coming up to our already magnificent arsenal of checklists by our QA team, and from my end, a lot of my efforts in establishing a TD is endless completion of checklists simplifying the work of the reviewers. Maybe I should shift my templates to corollate entirely with these checklists, instead of doing it free hand? Anyway, the main addition is the new Annex. This maps the standard's requirements to the General Safety and Performance Requirements of Annex I of the MDR. medicaldevices #MDR #LDPConsulting

Completed my certification in “ Medical Device Regulation : General Safety and performance requirements” Key points: Complete understanding of Annex I & II. Thanks to BSI

Do you already know the UK Responsible Person? 👩💼👨💼 With the move to UK MDR and #UKCA, there is a new role in the #conformity assessment of medical devices. Find out what’s behind it here. ➡ http://tuv.li/1k5a Manufacturers based outside the UK must appoint a legal entity based in the UK to act on their behalf as a UK Responsible Person. This person will take on several roles as part of the market introduction process. These include ensuring a conformity assessment procedure or registration with the #MHRA. 🏋♀️ Find out what else the UK Responsible Person is responsible for ➡ http://tuv.li/1k5a #UKResponsiblePerson #UKMDR #CE #medicaldevices #IVD #brexit #conformityassessment

Do you already know the UK Responsible Person? 👩💼👨💼 With the move to UK MDR and #UKCA, there is a new role in the #conformity assessment of medical devices. 𝐅𝐢𝐧𝐝 𝐨𝐮𝐭 𝐰𝐡𝐚𝐭’𝐬 𝐛𝐞𝐡𝐢𝐧𝐝 𝐢𝐭 𝐡𝐞𝐫𝐞 ➡ http://tuv.li/1kbQ Manufacturers based outside the UK must appoint a legal entity based in the UK to act on their behalf as a UK Responsible Person. This person will take on several roles as part of the market introduction process. These include ensuring a conformity assessment procedure or registration with the #MHRA. 🏋♀️ 𝐅𝐢𝐧𝐝 𝐨𝐮𝐭 𝐰𝐡𝐚𝐭 𝐞𝐥𝐬𝐞 𝐭𝐡𝐞 𝐔𝐊 𝐑𝐞𝐬𝐩𝐨𝐧𝐬𝐢𝐛𝐥𝐞 𝐏𝐞𝐫𝐬𝐨𝐧 𝐢𝐬 𝐫𝐞𝐬𝐩𝐨𝐧𝐬𝐢𝐛𝐥𝐞 𝐟𝐨𝐫: ➡ http://tuv.li/1kbQ #UKResponsiblePerson #UKMDR #CE #medicaldevices #IVD #brexit #conformityassessment

📣 To all medical device vendors with business in RCIS. Obviously, EU is discussing another package of sanctions focusing European subsidiaries. Theory or reality, stability is KEY for successful and sustaining business! You face issues related to the region? Just get in touch. #MistelLLC may have a solution also for you! E.g. our external Key Account Services. * Our talks reveal, manufacturers appear unsettled when it comes to actual and perspective business in RCIS. Justified? * The KEY market of the region is and remains the Russian Federation. * A strongly dominating regional key market means fundamental benefit to product preparation cost. * Actual conditions 👉 go along with difficulties to maintain direct/local vendor support 👉 go along with substantially increased cost of sales when supporting from the West and compared to local support. 👉 Support from within the region is KEY! * Risk means enhancing reluctance, leading to deprioritization, endangering actual turnover, blocking exploitation of opportunities. * Motivation and Mission is KEY. Our industry is bigger than pure business – medical technology means humanitarian contribution. #MistelLLC Com Services

𝐌𝐃𝐂𝐆 𝟐𝟎𝟐𝟏-𝟐𝟕 - 𝐓𝐡𝐞 𝐧𝐞𝐰 𝐐&𝐀 𝐨𝐧 𝐀𝐫𝐭𝐢𝐜𝐥𝐞𝐬 𝟏𝟑 & 𝟏𝟒 𝐨𝐟 𝐌𝐃𝐑 𝐚𝐧𝐝 𝐈𝐕𝐃𝐑 𝐚𝐝𝐝𝐞𝐝 𝐢𝐧 𝐭𝐡𝐞 𝐫𝐞𝐯𝐢𝐬𝐢𝐨𝐧 𝟏 Q11: Are Fulfilment service providers (FSP) as defined in Article 3(11) of Regulation 2019/1020 on market surveillance (MSR), considered economic operators under MDR/IVDR? Q16: Can the same natural or legal person assume the role of authorised representative as well as importer for one individual device under the MDR/IVDR? Explore together the latest Q&A 👇 #clariscience #mdr #medicaldevices #dispositivimedici #regulatoryaffairs

🔍 Demystifying the Responsibilities of an EU Authorized Representative in our latest blog post! Discover the essential role of the European Authorized Representative (EU AR) for medical devices in our comprehensive guide. ✏️ Verena Wieser talks about the pivotal responsibilities, from regulatory compliance to post-market surveillance. 💡 Gain insights into how we support non-EU manufacturers navigate the complexities of EU regulations every step of the way. Read more 👉 https://lnkd.in/dZwFU6Bz #EURegulations #AuthorizedRepresentative #ECRep #MedicalDeviceRegulation

Have you explored MDR’s platform for opportunities in licensing and professional regulation? RegulatoryJobs.org is designed by regulators, for regulators, with the sector’s unique needs in mind. We understand how challenging it can be for job seekers to find opportunities in this niche sector. Professionals often have to search individual websites, leading to frustration and missed opportunities. RegulatoryJobs.org solves this problem by bringing talent and job seekers together in one place — streamlining the process for both employers and candidates. Check it out today and simplify your search! Visit regulatoryjobs.org. #regulatoryjobs

#RegUpdatesWithRegDesk 1. For 𝗦𝗽𝗲𝗰𝗶𝗮𝗹 𝗔𝗽𝗽𝗿𝗼𝘃𝗮𝗹 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀, complete the attachment to the application and send it along with the informal particular approval application and relevant documents via email to 𝗺𝗽-𝘀𝗼𝗻𝗱𝗲𝗿𝘇𝘂𝘀𝘁𝗲𝗹𝗹𝘂𝗻𝗴@𝗯𝗳𝗮𝗿𝗺.𝗱𝗲. 2. The application should justify meeting the conditions of Article 59 MDR or Article 54 IVDR. Get daily regulatory alerts sent straight to your inbox - stay informed effortlessly! 𝗙𝗼𝗹𝗹𝗼𝘄: 👉 RegDesk and get daily regulatory alerts straight to your inbox. #medicaldevices #regulatoryapproval #MDR #bfarm #germany #rims

IVDD to IVDR transition ⭐ The 🆕 position paper from Team NB concerns the transfer of surveillance activities from one notified body to another for IVDD certified devices (legacy devices) that are transitioning to IVDR. The document outlines the structure of an agreement for such a transfer between the manufacturer of the device, the current notified body and the new notified body. https://lnkd.in/dUPAbhru #Medicaldevices #Diagnostics #EuropeanUnion #Regulatory #Compliance