Bartłomiej Skalny

▶ Post No. 4 about the upcoming revision of #ISO14607, Specific requirements for #mammary #implants. Let's talk about the new parameter #Surface #Complexity SC2 today, which becomes normative in the upcoming Annex G. In addition to roughness measurements, breast implant manufacturers shall report Surface Complexity, which provides a measure of the tortuosity of the surface and considers overhanging and hidden structures. While roughness measurements are conducted in normal direction to the implant surface, SC2 is measured in a 2D cross section of the shell. So, in preparation for the measurement, a clean and straight cross section must be cut from the shell. At INNOPROOF GmbH, we use the same die as for shell integrity testing in order to create a perfect cut. Next, a section of 4 mm length is visualized under the microscope. Our KEYENCE CORPORATION #VHX7000 is able to provide high contrast images of the cross section in the required resolution. Now, the profile of the surface is measured in terms of the actual length, avoiding islands and voids (see picture below). In order to calculate SC2, the measured actual length is divided by the straight length and the result is subtracted by 1. This means a completely smooth surface has an SC2 value of zero. Every texturization results in values higher than zero. The SC2 value will be reported together with average surface roughness in the future. We are prepared, so get your quote for SC2 measurements from INNOPROOF GmbH today! Get in touch with our CEO Daniel Klüß for more information.

8

🚀 SYNEKTIK Czech Republic Partners with Olomouc University Hospital for €16.4M Robotic Surgery Revolution! 🤖 In a groundbreaking move to enhance surgical capabilities, SYNEKTIK Czech Republic has secured a significant contract with Olomouc University Hospital to integrate the advanced da Vinci surgical robotic system. This €16,375,000 agreement not only encompasses the sale and installation of cutting-edge technology but also includes comprehensive personnel training and ongoing maintenance support. 💡 Key Highlights: - Enhanced surgical precision and improved patient outcomes - Commitment to cutting-edge medical technology - A model for future collaborations in healthcare innovation This partnership is set to transform surgical practices at Olomouc University Hospital, enabling more complex procedures with greater accuracy while reducing recovery times for patients. 🌟 As hospitals seek advanced solutions, collaborations like this will be pivotal in advancing medical robotics and elevating patient care standards. 👉 Click the link to learn more about this significant development! #HealthcareInnovation #MedTech #MedicalTechnology #MedtechCompanies #OlomoucUniversityHospital #Partnership #RoboticSurgery #SYNEKTIK #MarketAccess #MarketAccessToday

1

📢 𝗜𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁 𝗘𝗨𝗗𝗔𝗠𝗘𝗗 𝗣𝗹𝗮𝘆𝗴𝗿𝗼𝘂𝗻𝗱 𝗨𝗽𝗱𝗮𝘁𝗲 (𝘃𝟯.𝟵.𝟬)! 🗣 Attention medical device manufacturers in Europe! 🔔 The 𝗻𝗲𝘄 𝘃𝗲𝗿𝘀𝗶𝗼𝗻 of 𝗘𝗨𝗗𝗔𝗠𝗘𝗗 𝗣𝗹𝗮𝘆𝗴𝗿𝗼𝘂𝗻𝗱 (𝘃𝟯.𝟵.𝟬) has been released. Here are the main changes: 🔷 𝗔𝗰𝘁𝗼𝗿𝘀 𝗺𝗼𝗱𝘂𝗹𝗲: ✅ Fixed problems with user access requests and notifications. ✅ Improved display of Designated Authority details. 🔷 𝗨𝗗𝗜/𝗗𝗲𝘃𝗶𝗰𝗲𝘀 𝗺𝗼𝗱𝘂𝗹𝗲: ✅ Added registration for special types of devices, such as contact lenses and spectacle frames. ✅ Removed orthopedic device type. 🔷 𝗦𝘂𝗿𝘃𝗲𝗶𝗹𝗹𝗮𝗻𝗰𝗲 𝗺𝗼𝗱𝘂𝗹𝗲: ✅ Improved functionality of the MIR form. ✅ Added NRD management for old/customized devices. 🔷 𝗫𝗦𝗗 𝘂𝗽𝗱𝗮𝘁𝗲: ✅ The XSD schema version for this update is 3.0.10. ✅ You must adapt the XSD version number in your service requests before using the M2M service or the bulk upload service. 💡 Stay up to date on EUDAMED changes to ensure compliance with European regulations! 🤝 Contact us and find out how to comply with EUDAMED: https://lnkd.in/dreiWTp7 #EUDAMED #MDR #IVDR #MedicalDevices #EURegulation #Health Sandra Balseiro Viviana Gomes Ana Brito Celeste Oliveira Natalia de Souza Lescura Raquel Gomes Ana Catarina Silva Luiz de Pádua Queiroz Júnior

2

What are the requirements for the usability of medical devices? How can they be implemented into practice? Participate in the Usability of Medical Devices in Practice workshop 13.11.2024 in Kuopio and use the experts' tips for your own work. Why participate? 🎯 You will know the basics of usability and how to take it into account in designing and developing a medical device.  📚 You will have an insight into relevant standards and their connection to quality management and risk management systems. 💡 You will receive practical tips for your work and feedback on your medical device usability. 🤝 You will network and exchange ideas with colleagues. Please, note that the training capacity is limited to 30 first registered. Sign up by 4.11 at the latest. The training is in English. The training is free of charge: https://lnkd.in/gyTma_Ki The training is part of the ReguVa project (Boosting Regulation and Sustainability Competence for Health and Wellness Sector). The project is co-funded by the EU.    #SmartForGood #jatkuvaoppiminen #University of Eastern Finland #Medicaldevices  #ReguVa #KestavaaKasvua #UudistuvaOsaavaSuomi   University of Eastern Finland

3

💥 You don't want to miss this! Now it's your chance to learn how to successfully navigate the EMC testing procedure from start to finish! Join our webinar to gain insights into the crucial steps and key considerations for navigating the EMC testing procedure with ease. Hurry up! There's only 1 day left 😲 ⚡️Register Now⚡️ https://buff.ly/3xY2fgV #EMCtesting #compliancetesting #QualityAssurance #ElectromagneticCompatibility #electroniccompliance #EMCtest

6

Last week MedTech Poland took part in Impact24, the biggest and the most important economic congress in Poland and CEE in 2024 See our statement on the question during panel discussion: The medical devices industry was recognized by the government in past years as one of the smart specializations eligible for special support, which can give Poland a competitive advantage. What needs to be done to unblock the development of innovative medical devices in Poland? ''...according the data from annual report 2022 about the med tech sector received from MedTech Europe, Europe is home to 35,000 medical tech companies where, nearly 1 million people are employed, it’s slightly less than the well-known pharmaceutical industry. As far as Poland is concerned, only less then 30 thousand peoples have been working in MedTech sector. On the other hand, Poland is the fifth biggest market in Europe. regarding turnover in IVD This discrepancy between employment and market size demonstrates the potential for growth of development of innovative medical devices we have in our country.   Due to that Many local small & medium sizes including MedTech start-ups, companies from IVD sector very important for our health care system are faced of difficulties due to blurred legislative roles, limited access to f.e. foreign Notified Bodies which certify medical devices class C and D.  in short term; governmental institutions together with scientific centres and business experts should provide the support needed to develop the most strategic projects for IVD companies which as backbone for our economy and strengthen Poland's position on the European market. I hope that such a institutions as ABM - Medical Research Agency, NCBR - National Centre for Research and Development, AOTMiT -Agency for Assessment and Tariffication of Medical Technologies are as interested in cooperation between decision makers, industry and science society, what’s more  our opinions and recommendations should  be taken into account in the decision-making process regarding the selection and financing of medical procedures in our health care system.  Last but not least, their support should be much more effective and transparent for our sector as it has been in recent Times..."

6

MDCG 2024-16 Manufacturing Information Form has been published. The Manufacturer Information Form (MIF) is required under Article 10a of Regulation (EU) 2024/1860. This form is a crucial tool for manufacturers to notify competent authorities about anticipated supply interruptions or discontinuations of medical devices and IVDs. Here’s what you need to know: ✅ Purpose: Standardises notifications to competent authorities, ensuring consistent and actionable communication across the EU. 📋 Key Details Required: - Device identification (e.g., Unique Device Identifier). - Description and timeline of the supply disruption. - Reasons for the interruption (e.g., regulatory, manufacturing, supply chain). - Mitigation actions, such as stockpiling or alternative solutions. 📅 Effective Date: Manufacturers must use the MIF starting 10 January 2025 for mandatory notifications. Early voluntary notifications are encouraged for proactive compliance. 💡 Next Steps: Ensure your teams are familiar with the form's requirements and implement internal systems to monitor and assess potential supply risks. Stay ahead of these regulatory changes! For guidance on Article 10a compliance and navigating EU medical device regulations, connect with us at Specculo Limited. #MedicalDevices #IVDR #MDR #RegulatoryUpdates #EUMarketCompliance

8

2 komentarze

April 2024 MDCG 2024-4  Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746   #medicaldevice #wyrobymedyczne #ivdr #diagnostic #diagnostyka

3

🔔 ANNOUNCEMENT 🔔 Dr. Magdalena Żukowska from Poznan University of Technology will present a lecture, "3D Printing for Surgery Medicine," within the Joint Program for Virtual Mobility «Advanced Manufacturing: Innovations in Materials and Technologies». Dr. Zukowska, a specialist in #biomedicalengineering, will share how 3D printing is opening new frontiers in surgical applications. Her lecture focuses on the: 💡 the possibility of manufacturing highly complex shapes of engineering products; 💡 topics related to anatomical models; 💡 case studies and practical insights. #iatdi #education #virtualmobility #3Dprinting #medicalinnovation

3

This seminar will be held in English! 🔆 The development of standalone software such as mobile medical applications but also the integration of software as a component in medical devices 👩‍💻 means a complex challenge for many medical device manufacturers in the intersection of technology, regulations and clinical evidence. 👍 In this seminar, you will gain an overview of the regulatory framework and familiarize yourself with the specifics of placing medical software on the market. 😉 The requirements for classification and conformity assessment procedures of medical software in the most important markets will be shown to you in a practical manner and using current examples. ➡ You will learn about all phases of the product lifecycle of medical software, starting with development, through initial marketing, to software maintenance (i.e. updates and bug fixes). ➡ Your Trainer Martin Schmid will show you what is important ⚠ when placing products on the market in the most important markets and how you can integrate the required processes into your quality management system in a meaningful way. 👩‍🎓 This basic course is part of our online course: Medical Software Specialist! https://lnkd.in/ey_hj6Gk) 💰 Don't miss the deadline to apply for a SCHOLARSHIP (worth each à € 490,--!!) for this online course: https://lnkd.in/dA_wepWR 💰 🎫 info and registration for "development of software for medical devices" on October 11, 2024: https://lnkd.in/dxvt3n68 🤑 Save money and take advantage of our early booking bonus if you book 4 weeks before the seminar date 🤑 #software #development #health #medicaldevice #specialist

4

This seminar will be held in English! 🔆 The development of standalone software such as mobile medical applications but also the integration of software as a component in medical devices 👩‍💻 means a complex challenge for many medical device manufacturers in the intersection of technology, regulations and clinical evidence. In this seminar, you will gain an overview of the regulatory framework and familiarize yourself with the specifics of placing medical software on the market. 😉 The requirements for classification and conformity assessment procedures of medical software in the most important markets will be shown to you in a practical manner and using current examples. ➡ You will learn about all phases of the product lifecycle of medical software, starting with development, through initial marketing, to software maintenance (i.e. updates and bug fixes). ➡ Our Trainer Martin Schmid will show you what is important when placing products on the market in the most important markets and how you can integrate the required processes into your quality management system in a meaningful way. 👩‍🎓 This basic course is part of our online course: Medical Software Specialist! (https://lnkd.in/ey_hj6Gk) ⚠ 💰 Don't miss the deadline to apply for a scholarship (worth each à € 490,--!!) for this online course! => further information about the scholarship: https://lnkd.in/dZwzeg5k 🎫 info and registration for development of software for medical devices on October 11, 2024: https://lnkd.in/datChzEs 🤑 Save money and take advantage of our early booking bonus if you book 4 weeks before the seminar date (=> booking before Friday September 13, 2024) 💰 #software #development #health #medicaldevice #specialist

3

BSSH is conducting a report on the risks and benefits of sterile packed screws and implants in hand TRAUMA. 📋💡 With recent shifts in surgical implant traceability and new EU Medical Device Regulations, healthcare providers are increasingly adopting sterile packed options. But is this the best choice for our patients? 🤔💭 We need input from BSSH members expertise to shape national policy and enhance hand surgery care. 🌟 Please take a moment to complete our short survey. Look out in your inbox for the survey link. #BSSH #HandSurgery #PatientCare #MedicalResearch #SurgeonCommunity

5

Deliveries of complex medical equipment continue: Chernivtsi, Ivano-Frankivsk and Voznesensk received modern MRI scanners! The Ivano-Frankivsk Regional Clinical Hospital received an MRI scanner with a magnetic field strength of 3 Tesla, manufactured by Canon Medical Systems Corporation, Japan. The Voznesensk Multidisciplinary Hospital and Chernivtsi Regional Clinical Hospital received MRI scanners with 1.5 Tesla, manufactured by Siemens Healthcare GmbH, Germany. Last year, we purchased 28 MRI scanners at the request of Ministry of health of Ukraine: 22 with 1.5 Tesla and 6 with 3 Tesla field strength. Of these, 6 MRI scanners with 1.5 Tesla and 2 with 3 Tesla have already been delivered to hospitals in Pavlohrad, Khmelnytskyi, Ternopil, Sumy, Chernivtsi, Voznesensk, Dnipro, and Ivano-Frankivsk. Generally, MRI machines are divided into: 🔸 Low-field (up to 0.5 Tesla), 🔹Mid-field (up to 1 Tesla), 🔸High-field (1.5 Tesla and above). ❓ What is the difference between the machines? The difference lies in diagnostic efficiency. Machines with 0.5 or 1 Tesla lack sufficient power for all diagnostic needs and are slower. In contrast, machines with 1.5 Tesla and 3 Tesla are more powerful: 🔸 1.5 Tesla MRI is considered the gold standard in diagnostics, sufficient for detecting diseases during the initial diagnosis. It can scan any part of the body, including the abdominal cavity, pelvis, bones, joints, and breasts. 🔹 3 Tesla MRI is recommended for in-depth imaging of blood vessels, nerve endings, and other intricate structures. However, when a patient has prosthetics, braces, or other metal elements, a 1.5 Tesla MRI is preferable. The hospitals underwent a long and demanding process to prepare rooms for the MRI scanners, ensuring compliance with all requirements. However, there’s still work ahead, as commissioning the devices takes about three months. #medical #procurement #hospitals #MRI #scanners #equipment #diagnostic #diseases #patients #treatment #deliveries

21

🔊 Want to learn how to maximize your investment in an intraoral scanner and diagnostic software, beyond just collecting digital impressions? Join our English-speaking webinar featuring Dr. Pawel Paszkiewicz, a top dentist specializing in digital Prosthodontics. Discover the wide-ranging benefits of having intraoral scanners in your office and digitizing your workflows.   Registration here 👉 https://lnkd.in/ekU-KsCe #DigitalDentistry #IntraoralScanners #DEXIS #DigitalWorkflow

17

The medical industry is growing in both the technical and online sectors. New solutions proposed by doctors and device manufacturers allow for professional patient care, research or drug analysis. In order for the devices to work properly, they must be operated by specialists who know more than just professional terminology. Solutions applied at the technology level need to be used appropriately so as not to endanger either the patient or the users and prevent malfunction of the expensive equipment. A medical device manual is an example of documentation that requires specialist knowledge to develop. The same is true for the translation of this type of content. Precision and accuracy are important not only in a linguistic context. Correct rendering of highly specialised terminology in another language sometimes requires the translator to have a medical background. What else is worth knowing about translating medical texts? Read more: https://lnkd.in/dfH9K3wg

1

Is your custom device MDR-compliant? 🤔 Discover crucial regulations in the shared article. Or, connect with Vivien directly to access Regulatory Assurance and Quality Management experts seeking new opportunities. 📈 #MedicalDevice #MDRCompliance

3

IEC 62366 – Usability Engineering for Medical Devices🦼 ✔️ Standards are necessary for the better functioning and regulation of different manufacturing and industrial sectors. And when it comes to the healthcare sector, their importance increases to a thousand folds.😀 ⭐ IEC 62366 is also one of such standards. Devised by IEC, this standard is divided into two parts. Part one of this standard aims to regulate the application of usability engineering to medical devices whereas its second part assists manufacturers in complying with the requirements of part 1 of this standard.✔️ Link to complete article https://lnkd.in/emcnDPx #tsqe #iec62366 #usabilityengineering #iec #healthcare #medicaldevices

2

1 komentarz

#𝗠𝗲𝗱𝗶𝗰𝗮𝗹𝗗𝗲𝘃𝗶𝗰𝗲 𝗱𝗲𝘀𝗶𝗴𝗻 𝗿𝗲𝘃𝗶𝗲𝘄 is a valuable chance to stop and evaluate the situation when you are developing a medical device. Are the design requirements adequate? Is the design likely to meet these requirements? Are there any problems that are yet to be identified? 📽 In this video, you will find out more about how to best conduct a design review and what pitfalls to watch out for. https://lnkd.in/efKkQWZ #Medtech #DesignControl

35

2 komentarze