i-Pharm Consulting’s Post

Top Trends Shaping Safety in the Medical Device Package Validation Market.

Regulatory is continuously changing!

🎤 Speaker Spotlight: Christine Cwieka🎤 We’re thrilled to highlight one of our speakers, Christine Cwieka, Human Factors Engineer at Design Science Group, LLC, for the Prefilled Syringes & Injection Devices 2024 event! 🌟 In this role, Christine collaborates with clients as their human factors expert to design and execute usability studies in accordance with Human Factors standards and guidance and meets the expectations of FDA and international ministries of health. Christine’s presentation will focus on how Human Factors engineering impacts the safe use of drug delivery systems, such as pre-filled syringes and injection devices. As more treatments shift to at-home care, patients and caregivers are taking on greater responsibility. Christine will explain the importance of minimizing user errors and ensuring drug delivery is effective. She’ll also emphasize the need to integrate Human Factors early in the development process to meet regulatory requirements and avoid issues later on. Join us in December! https://lnkd.in/e7T2MgSn 💥 #PrefilledSyringes2024 #InjectionDevices #PharmaceuticalInnovation #MedicalDevices #IndustryLeadership #DesignScience #PFS #PharmaEd

Everything you need to know about biocompatibility - in one video: https://lnkd.in/gyBVSzBf Marina Daineko from Intrinsic Medical Group, LLC and I got together in early September to chat about biocompatibility, which, if you didn't already know, is a crucial aspect of medical device development. All the major regulatory agencies have some measure of biocompatibility requirement, and it's not always easy to know exactly what you need for a given device. There's a LOT to consider when talking about biocompatibility testing, namely the challenges of material selection, device design, and testing limitations. Not to mention the ever-evolving regulations and standards. Oh and we also talked about best practices for achieving biocompatibility, including comprehensive testing, risk-based approaches, collaboration with experts, and continuous monitoring. In other words, we had a rollicking good time. 😆 Check it out. You can read even more about biocompatibility and the FDA here: https://lnkd.in/g9hm2gu3 But if you have a pressing biocompatibility problem or question, put some time on my calendar and we'll chat: https://leanraqa.com/time #medicaldevices #qualitymanagement #compliance #regulatoryaffairs #medtech #biotech #FDA #510k #biocompatibility

TGA News! (Personalised Devices) Australia’s Therapeutic Goods Administration (TGA) has today (17 October) published updated guidance's for personalised medical devices which are devices that are either designed and manufactured, or modified after they are supplied, to suit an individual. The three updated guidance's are: • Refinements to the Personalised Medical Device Framework: https://lnkd.in/eKwzmbCd • Understanding personalised medical devices rules (including 3D-printed devices): https://lnkd.in/e2HSTAbV • How to submit a custom-made medical device and patient-matched medical device notification - step-by-step guide: https://lnkd.in/eT3CHka5 These documents provide information and examples to help you understand the personalised devices framework and meet your regulatory obligations. For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us.   #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #ivdr #mdr #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #tga #customdevices

💡ESSENVIA ESSENTIALS: THE FDA IS REMINDING MEDTECH MAKERS THAT IT ADDED TWO TECHNICAL INFORMATION REPORTS (TIRs) to its Recognized Consensus Standards Database in a newsletter released on July 17 by the US agency’s Division of Standards and Conformity Assessment. These are the TIRs added to the FDA’s so-called “List 62” of its standards database: 👉AAMI TIR12:2020: Revised in 2023, this TIR urges manufacturers to develop instructions for processing steps to accompany reusable and single-use medical devices processed by healthcare facilities before clinical use; and  👉AAMI TIR28:2016: Revised in 2020 and augmenting the FDA-recognized standard ANSI/AAMI/ISO 11135, this TIR gives guidance to manufacturers and sterilizers when they add new or modified products to an existing validated ethylene oxide (EtO) sterilization process. You can check out the FDA’s full suite of recognized standards by visiting https://rb.gy/zej9ku. 💡Essenvia Essentials: Bite-Sized MedTech News for RA Professionals💡 Founded in 2018, Essenvia is a MedTech RIM platform that gives you the tools you need to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value. Discover more about what Essenvia can do for your MedTech company at Essenvia.com. #FDA #CDRH #Standards #Regulatory #MedTech #MedicalDevices #Essenvia #RIM #RegulatoryManagement

Discover new pathways to professional success with the Drug and Medical Device Development: A Strategic Approach program from #MITxPRO and gain insights on strategies that drive success in today's competitive landscape. Join the program now: https://lnkd.in/daEWwddu #MITxPRO #ExecutiveEducation #DrugDevelopment #MedicalDevice #Biotech #HealthcareInnovation

https://conta.cc/3BFuVgM The Florida Medical Manufacturers Consortium (FMMC) invites you to special South Florida facility tour and briefing focusing on "High Volume Manufacturing in a Regulated Environment." The event will provide valuable insights into innovative technologies and manufacturing strategies employed by International Medical Industries (IMI)—an industry leader in sterile and non-sterile medical devices. Explore and learn how IMI is navigating the challenges of large-scale production while ensuring compliance, quality, and innovation. Whether you’re interested in manufacturing process innovation, regulatory compliance, or scaling production in a regulated environment, this event is for you. #medicaldevice #regulatory #quality #manufacturing #medtech

Medical Device Labeling Market refers to the #industry involved in the design, production, and regulation of labels for medical devices. Labels provide essential information about the device, including usage instructions, safety warnings, #manufacturer details, and compliance with regulatory standards. This market is crucial for ensuring that medical #devices are used safely and effectively, as well as for meeting legal requirements set by health authorities. The market is influenced by advancements in #technology, regulatory changes, and the growing demand for medical devices globally. Get more on: https://lnkd.in/dvaRygRN #MedicalDeviceLabeling #MedTech #RegulatoryAffairs #MedicalDevices #LabelingCompliance #HealthcareInnovation #DeviceSafety #PatientSafety #FDARegulations #Biotechnology

𝐏𝐚𝐫𝐥𝐢𝐚𝐦𝐞𝐧𝐭𝐚𝐫𝐲 𝐩𝐚𝐧𝐞𝐥 𝐟𝐥𝐚𝐠𝐬 𝐠𝐚𝐩𝐬 𝐢𝐧 𝐭𝐞𝐬𝐭𝐢𝐧𝐠, 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐧𝐠 𝐫𝐚𝐝𝐢𝐚𝐭𝐢𝐨𝐧-𝐞𝐦𝐢𝐭𝐭𝐢𝐧𝐠 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞𝐬 In its fifth report, the Parliamentary Standing Committee on Consumer Affairs, Food, and Public Distribution has flagged significant gaps in the testing framework for critical medical equipment like x-ray and MRI machines. Despite existing regulatory oversight from the Atomic Energy Regulatory Board and Central Drugs Standard Control Organization, the National Testing House lacks the expertise and capacity to test and certify radiation-emitting medical devices comprehensively. The panel has pitched for setting up at least one testing center in each state. #report #committee #flagged #MRI #xray #medical #devices #equipment #testing #radiation #emitting