Khushboo Surendran, MS

Are you ensuring that your product design aligns with FDA guidelines? The Use-Related Risk Analysis (URRA) is an essential tool for identifying potential use errors and implementing effective risk control measures. Ensuring that every step of the URRA processfrom identifying user tasks to implementing effective risk control measuresis vital for maximizing user safety and minimizing potential hazards. Keep your patient safety at the forefront by understanding the steps involved in URRA development. #MedicalDevices #FDA

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★ Increase in QMS Risk Management Requirements under the QMSR ★ Medical device companies that need to transition to the QMSR and do not currently follow ISO 13485:2016 could have many gaps in their QMS. One significant difference between the current QSR and the requirements under the QMSR is in risk management, which is mentioned throughout ISO 13485:2016. With the QMSR the FDA is shifting to a more integrated risk management approach. It requires medical device companies to consider risk not just as a one-time analysis activity as in the QSR, where risk is only considered once in the design validation requirements, but now the risk management process will be integrated into every aspect of the medical device lifecycle. We offer a QMSR Gap Analysis Checklist to identify all QMS gaps, including for risk management. Link:  https://lnkd.in/gSbjhEnN To better understand the QMSR, we have added a QMSR Transition to ISO 13485:2016 slide deck + 3 QMSR Guidance Manuals plus Transition Planning Form Templates. On downloading the checklist you will receive these free documents by email. #iso13485 #qualitymanagement  #qualityconsulting #riskmanagement

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Are you dreading an upcoming regulatory agency inspection? FDAQRC’s Inspection Readiness Program can help you feel confident and prepared! FDAQRC’s Inspection Readiness services are personalized for each project to ensure they meet quality and regulatory standards. We offer audits, training, GAP analysis, and much more to fit your project’s exact needs. Interested in discussing our Inspection Readiness program? Fill out our form and our team will reach out to you! https://hubs.ly/Q02VjYhz0 #inspectionreadiness #regulatorycompliance #audits #FDA #EMA #regulatoryagency #inspection

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The transition to a Quality Management System Regulation (#QMSR) has effectively superseded the explicit medical device design controls CFRs and associated FDA guidance, though their essence lives on, write Jayet Moon and Arun Mathew in this new Drug Delivery Leader / Med Device Online article. https://lnkd.in/eEbJji4t #medicaldevices #designcontrols #regulatorycompliance #qms

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Has your organization found itself constantly adapting to the medical industry’s rapidly changing technology and regulations? MasterControl can help with this! Download this eBook to discover how a properly implemented QMS from Mastercontrol solves issues for industry professionals. 👍 https://lnkd.in/drc9n7k2 #QMS #Mastercontrol #Compliance #Regulations #MedicalIndustry #MedicalDeviceManufacturing #Technology

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For those of you struggling to decipher the FDA's ruling on LDTs, here's a great breakdown of the key points covered in Tuesday's FDA-led webinar. Thanks to Christine P. Bump for putting this summary together. ============================================ ‌ I’m Leslie, a life science writer skilled in translating complex science into persuasive copy. I leverage my 30+ years' experience in the medical device, laboratory, regulatory and healthcare industries to create copy that will boost conversions and fill your funnel. ‌ #medicaldevices #compliance #laboratory #regulatoryaffairs #contentmarketing #qualitymanagement #writing #contentstrategy #lifesciences #marketingcontent #copywriting #contentcreator #stemcells

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6 Tests to Identify Foreseeable Misuse in Medical Devices ISO 14971 requires identifying "reasonably foreseeable misuse" of medical devices. But how do you determine whether it's a use-failure or actual misuse? ➔ 𝐃𝐞𝐥𝐢𝐛𝐞𝐫𝐚𝐭𝐞 The user has intentionally chosen to use the device differently than intended. This means that the action is not accidental; the user makes a conscious decision to use the device in a way that is not outlined by the manufacturer. ➔ 𝐖𝐞𝐥𝐥-𝐈𝐧𝐭𝐞𝐧𝐭𝐢𝐨𝐧𝐞𝐝 The user aims to benefit the patient; no harm is intended. For instance, a healthcare provider might use a device off-label because they believe it could help the patient in a specific situation, even though the device was not designed for that exact use. ➔ 𝐁𝐞𝐧𝐞𝐟𝐢𝐜𝐢𝐚𝐥 The user believes their approach will bring value to the patient. This means the misuse is motivated by a desire to improve patient outcomes. The healthcare professional might think that using the device in this new way will have a positive effect on the patient's condition. ➔ 𝐅𝐞𝐚𝐬𝐢𝐛𝐥𝐞 The misuse is within the user's technical, financial, and skill capacity. In other words, the user has the necessary knowledge, skills, and resources to carry out the misuse. This is important because if the misuse is too complicated or costly, it is unlikely to occur in practice. ➔ 𝐒𝐚𝐟𝐞 The user believes the misuse can be done safely. This means that the user has assessed the potential risks and determined that, in their judgment, the misuse will not cause harm to the patient. Safety is a key consideration, as the user must believe that their actions will not introduce unacceptable risks. ➔ 𝐄𝐭𝐡𝐢𝐜𝐚𝐥 The user discloses the truth and obtains patient and hospital consent (not relevant if a patient uses the device on themselves). Ethical considerations are essential, especially when the intended use is altered. The user must be transparent with the patient and healthcare institution and must ensure that the patient fully understands and consents to the new way the device is being used. If a misuse scenario meets these six criteria, it should be considered reasonably foreseeable and addressed in the device's risk management plan. Note that malicious misuse, where the intent is to harm, is excluded from the risk management of the medical device.

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✳️ Supplier Approval and Management for Medical Device Companies. ✳️ those who need to transition to the QMSR and do not currently follow ISO 13485:2016 requirements will likely have significant gaps in their QMS. One of these could be documented procedures for supplier approval and management which has more specific requirements including risk as a criterion for the evaluation and selection of suppliers as well as ongoing purchased product verification activities. For our proven supplier approval and management procedure templates that meet the QMSR and ISO 13485:2016 requirements, here is a link to our ISO 13485 Store: https://lnkd.in/gSgcCuEJ 📗  Read our block on supplier management: https://lnkd.in/gav8sk-N To help identify all potential gaps we have a comprehensive 41-page QMSR Gap Analysis Checklist available for download: https://lnkd.in/gSbjhEnN Additional QMSR transition training materials and supporting documents are included with the QMSR Checklist and will be emailed within 24 hours of downloading the checklist. Looking for expert support with your QMSR transition contact us at: https://lnkd.in/gqvCkhny #fdaqmsr #iso13485 #qualityconsulting #suppliermanagement

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As a former FDA investigator, Vincent F. Cafiso has heard — and seen — it all when it comes to what NOT to do during an FDA inspection. Here he gives some good advice on who you should have present in the room during an inspection and how you should interact with the investigator. https://lnkd.in/gQWweVmY #FDA #Clinicaltrials

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Pivotal Study in Medical Devices: ISO 13485:2016 Compliance A pivotal study is essential for validating the safety and effectiveness of medical devices. Study Design & Objectives: Clearly define study goals to assess product safety, efficacy, and compliance. Regulatory Adherence: Ensure study protocols meet regulatory standards and are approved by relevant authorities. Data Integrity: Collect, monitor, and analyze data to maintain accuracy and reliability throughout the study. Risk Management: Identify and mitigate risks to safeguard patient safety and product performance. #ISO13485 #PivotalStudy #MedicalDevices #Compliance #QualityManagement #ClinicalTrials #PatientSafety #Qualityassurance #Regulatoryaffairs

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Predetermined change control plans are relatively new concept at FDA but have already been included in several dozen device authorizations to streamline FUTURE modifications. Everything from updating Apple's Apple Watch arrhythmia app algorithms to integrating new CGMs and insulin pumps CamDiab's glycemic controller app to adding new "trajectories" and design modifications to SI-BONE's pelvic implant system. These are all examples I discussed in a Market Pathways article (* https://lnkd.in/gY5pZVxD *) on the state of PCCPs at FDA, including some data, and also insights from Medtronic's Yarmela Pavlovic, Epitel's Christopher Phillips, MSHS, RAC, Amazon's CMDA Shilpa Prem and FDA's Jessica Paulsen from the recent Regulatory Affairs Professionals Society (RAPS) meeting. Details and stats on devices that have undergone PCCPs relied directly on Brendan O'Leary's targeted search function and listing: https://lnkd.in/gxiGyvc4 - Brendan is doing yeoman's work re: extracting useful information from PDF files embedded in FDA databases. ALSO: I'm interested in interviewing companies that have gone through a #PCCP process with FDA about the experience and lessons-learned for Market Pathways. If your company fits that description and you're interested, reach out to me! #medtech #digitalhealth #AI #regulations #FDA #medicaldevices

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Data-Driven Decision Making Struggling to track nonconformities? With qmsWrapper, you can quickly record data and export detailed reports for analysis. Keep your QMS on track. #MedDev