Test Labs - Medical Devices

📌 Medical Device Manual Cleaning: Everything You Need to Know 🔵 According to ISO 17664, manufacturers must provide comprehensive information on cleaning, disinfection, and sterilisation processes in their IFUs. Each step must be validated to support the manufacturer’s claims. Read more: https://lnkd.in/eHAnUSJ6 #medicaldevices #iso17664 #fda #mdr

📌 Handheld Medical Device Material Compatibility – Case Study 🔵 The increased frequency of cleaning practices has accelerated the wear and tear of medical devices, leading to higher failure rates, especially when harsh disinfectants are used instead of recommended mild detergents. 🔵 Material compatibility testing helped identify critical damage points in devices exposed to incompatible disinfectants, guiding manufacturers to develop more durable materials and update cleaning instructions, ensuring equipment longevity and compliance with modern healthcare demands. Read more: https://lnkd.in/eNffPDKh #medicaldevices #casestudy #materialcompatibility

Laurie Rowe from Red Medtech: "Looking ahead, the medtech industry faces evolving regulatory landscapes, including the increasing demand for connected devices, and the integration of AI and machine learning. In this dynamic environment, the role of development engineers becomes even more crucial." Get your copy of Outlook, reach out to us, and we'll gladly send one your way. https://lnkd.in/dMfXqxyW #medicaldevices #ai #machinelearning

📌 IEC 60601-1 Pre-Compliance Evaluation Discover our IEC 60601-1 Pre-Compliance Testing process with James, our dedicated laboratory scientist specialising in product testing. In this overview, James walks through the key equipment used during the testing process and explains how we integrate it with cleaning and disinfection validation. This combined approach helps medical device manufacturers ensure their products meet regulatory requirements efficiently and effectively We've opened the door to testing at testlabsuk.com Contact us to discuss your testing requirements – https://lnkd.in/e2b6q7JH #medicaldevices #IEC60601 #laboratory

Our greatest strength lies in our people – their expertise, dedication, and passion form the foundation of our success. In this edition of Expert Spotlight, we’re excited to introduce Holly Scott, our Executive Assistant and Accounts Manager. Holly’s role is multifaceted – she ensures seamless client experiences, manages project schedules, and oversees important systems like our CRM and KPI dashboards. With a background in customer service and administration, she brings a unique blend of organisation and empathy to her work. Read more: https://lnkd.in/eug5HbRy #medicaldevices #laboratory #expert

Anisha Rose Chacko from Advena Ltd (UK): "MDR demands higher quality and more comprehensive clinical evidence compared to the MDD/AIMDD. Ensure your clinical evaluation is comprehensive and well-structured, in particular, collection and presentation of robust clinical data from the literature, supplemented with any available data for your device, providing scientific justifications, including thorough risk analysis and mitigation strategies." Get your copy of Outlook, reach out to us, and we'll gladly send one your way. https://lnkd.in/dMfXqxyW #medicaldevices #decontamination #materialcompatibility

Enrico Allegra and Sophie Bell will be speaking at R&Y International "2nd Annual Medical Device Biocompatibility Conference" today, discussing how BEP's ensure a smooth sailing journey for the life-cycle of a device. #medicaldevices #biocompatibility

📢 Discover all your testing requirements in just 3 clicks at www.testlabsuk.com #medicaldevices #customerservice

Good first day here at the 2nd Annual Medical Device Biocompatibility Conference. Lots of very interesting talks from many industry experts. It was great to hear a nice overview of the 10993 series approach from Paolo Pescio, ERT. It was coincise and effective touching many areas and challenges of this field. Great follow up talks and I particularly enjoyed Erik Vollebregt telling us more about the legal aspects of biocompatibility. Thanks as well to Silvia Georges, Ph.D., Sandi Schaible, Elena Henderson and Alina Martirosyan sharing knowledge on how to interpret data for submissions and the importance of toxicological risk assessment. Great to hear as well the experience of Michael Thaller on FDA and NPMA submission and special thanks to Crystal D'Silva as chair of the event and for sharing your experience with us. Looking forward to tomorrow! R&Y International Test Labs - Medical Devices

Chris Hill from PDI : "Decontamination requires a balance between disinfectants strong enough to eliminate harmful bacteria and gentle enough to preserve the integrity of medical devices, crucial for saving lives. Surface material compatibility is key, as it involves the interaction between device materials and disinfectant ingredients." Get your copy of Outlook, reach out to us, and we'll gladly send one your way. https://lnkd.in/dMfXqxyW #medicaldevices #decontamination #materialcompatibility