At DocuRegs, we've been busy since the holidays and still going, preparing and creating insightful information for you. Our goal is to help you start 2024 armed with knowledge in MedTech regulatory, quality, and engineering. We've recently launched a YouTube channel featuring video content on, #PMCF #FDA predicate devices and classification #ISO13485 development #SupplierManagement #RiskAssessment #Vigilance, and more! ????????Please visit our channel, subscribe, share, and like to stay informed. ???????????????? ??-?????????? ???????????? ???????? ?????????????? ????????: ??"????????????????: ???????????????????? ???????????????????? ?????? ?????????????? ???????????? & ???????????????????? ??????????????????????????." Co-Authors: Mike B. Wetherington and Leonard (Leo) Eisner Eisner, "The IEC60601 Guy." ??"???????????????????? ?????? ?????????? ?????????????? ???????????? ???????????????????? ??????????????????: ?? ?????????? ?????? ???????????????????? ?????????????? ??????????????????????????." Co-Authors: Mike B. Wetherington and Adam Isaacs Rae. ??"???????????????????? ?????? #SaMD ???????????????????? ????????: ?? ?????????????????????????? ?????????? ?????? ???????????????????? ?????????????? ??????????????????????????." Co-Authors: Mike B. Wetherington and Karandeep Singh Badwal. ??"Navigating the LATAM Regulatory Landscape: ?? ?????????????????????????? ?????????? ?????? ???????????????????? ?????????????? ??????????????????????????." Co-Authors: Mike B. Wetherington and Rishi Dewan MPharm, MSc, MTOPRA. At DocuRegs, our focus is on collaboration and contribution for the benefit of the community. If you have valuable insights on specific areas in #MedTech regulatory, quality, and engineering, we would love to hear from you. DocuRegs "???????????????? ????????????????????, ??????????????, ?????? ??????????????????????." ?? ??????-???????????? ??????????????????????. https://lnkd.in/gBK4ZzVW
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Navigating MedTech Success: Bridging Regulatory, Quality, and Engineering with Expert Tools and Insightful E-books.
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Welcome to DocuRegs LinkedIn Page! (Sister company of MedicalRegs) ?? Elevating MedTech Excellence ?? At DocuRegs, we're your dedicated partners on the journey to MedTech success. With a focus on Regulatory Affairs (RA), Quality Assurance (QA), and Medical Engineering, we're here to empower innovators like you with the tools, knowledge, and insights needed to thrive in the ever-evolving world of medical devices. ?? Your Trusted Guides: Our team of seasoned experts brings a wealth of experience across the MedTech spectrum. From deciphering complex regulatory landscapes to crafting innovative quality solutions and engineering advancements, we're here to guide you every step of the way. ?? Expertise in Your Hands: As advocates of continuous learning, we've curated a library of e-books that provide comprehensive guidance on medical device regulatory pathways, quality assurance best practices, and medical engineering standards. Dive into our resources to stay ahead of the curve. ?? Crafting Excellence: We believe that excellence isn't just a goal; it's a way of doing things. Our RA/QA tools are meticulously designed to streamline processes, enhance compliance, and fuel your growth. Because your success is our success. ?? Igniting Innovation: In the dynamic MedTech landscape, innovation is the driving force. Through our e-books and resources, we inspire creative thinking and bridge the gap between regulatory, quality, and engineering realms, ensuring your ideas come to life. Join us on this exhilarating journey of MedTech innovation and advancement. Follow our page to access valuable insights, stay updated on industry trends, and be a part of a community that's committed to shaping the future of healthcare. Let's navigate the path to MedTech success together! ??
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- Jacksonville
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- 2023
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- Medical Device Regulatory Compliance、ISO13485、ISO14971、Risk Management、IEC60601、ASEAN Regulatory、Quality Management System、FDA 510k、CMDR、Home Healthcare Devices、Robotics、CAPA、PMS、PMCF、Clinical、Risk Assessment、Technical Documentation File、Product Safety、CB Scheme、Risk Mitigation、Risk Control、EU MDR、510k、Health Canada、QMS、Supplier Evaluation和Product Safety Certification
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DocuRegs转发了
Helping Medical Device Companies Achieve Regulatory Approval & Quality Compliance | Regulatory Affairs Quality Consultant | ISO 13485 QMS | EU MDR | Digital Health SaMD US FDA | Speaker | Host of The MedTech Podcast ???
???????? ?????????????? ???????????????????? ???????????????????? ?????????? ???? ????????? How you may ask? Let me break it down for you. CPI is once again opening doors to an incredible opportunity. They're offering up to ￡30,000 in funding for regulatory affairs advice. Yes, you read that right. Here's why you need to jump on this: → It's not every day you get access to quality regulatory advice without a price tag → Perfect for MedTech entrepreneurs and small to medium medical device companies looking for guidance → Skip the usual hurdles and fasttrack your regulatory strategies So, how do you get on board? Apply via this link: https://lnkd.in/eeTNHvkv Be quick! Deadline is 31st October or until they hit 300 applications. Remember, opportunities like this don’t come around often. Ready to take your regulatory affairs to the next level? The clock’s ticking!
MedTech Accelerator: Rapid Regulatory Support Fund Programme… | CPI
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DocuRegs转发了
Founder & Publisher | MedTech, Life Sciences, HealthTech | MDR/IVDR, QA/RA | Leading Voice Program | Worker ??
Please Repost: Less than 1 week until HealthTech LATAM ???? Our first-ever Spanish language webinar (Webinar gratuito en Espa?ol) Join us Wednesday, Sept 18 at 11:00 AM ET/10:00 AM COL/CT Register Now https://lnkd.in/gT8EHR-K Llevar tu HealthTech a EEUU: Retos y Oportunidades de LATAM ?Estás desarrollando HealthTech en América Latina y buscando ingresar al mercado de EE.UU.? únete a nosotros en el Webinar Gratuito HealthTech LATAM, donde desmitificamos el proceso de autorización de la FDA y proporcionamos conocimientos prácticos para ayudarte a lograr la aprobación 510(k). Lo Que Aprenderás: ? Desarrollo de Software de Tecnología Médica - Por Dónde Empezar: Obtén una visión general completa del proceso de presentación 510(k), incluyendo los requisitos regulatorios clave y la documentación necesaria para la autorización de la FDA. ? Desafíos para Empresas de Tecnología Médica en América Latina: Aprende sobre los desafíos comunes que enfrentan las empresas en América Latina y cómo superarlos, con un enfoque especial en las prácticas de documentación de calidad. ? Estrategias para el éxito: Descubre estrategias paso a paso para agilizar tu proceso de presentación 510(k), mantener el cumplimiento y prepararte para las auditorías de la FDA. ? Perspectivas de Expertos: Escucha a expertos de la industria y empresas exitosas que han navegado por el proceso 510(k). Participa en una sesión de preguntas y respuestas para obtener respuestas a tus preguntas específicas. Speakers: ? Lina Maria R.: Fundadora y Consultora, Lucid RA ? Juan M Fernandez: CEO y Fundador, SmartTIVA Inc. ? Angela Maria Lema-Pérez: Especialista en Asuntos Regulatorios, TECHFIT Digital Surgery Inc. ?? Fecha y Hora: ? Miércoles 18 de septiembre 2024 ? 10:00 AM COL/CT. 11:00 AM ET ?Por Qué Asistir? ? Orientación de Expertos: Aprende de los principales expertos en el campo de la regulación de dispositivos médicos y desarrollo de software. ? Ejemplos del Mundo Real: Benefíciate de ejemplos prácticos y casos de éxito. ? Pregunta a los Expertos: Participa en una sesión de preguntas y respuestas con expertos para obtener respuestas a tus preguntas específicas.?See less >> HELP US SPREAD THE WORD BY REPOSTING THIS! #latam #medtech #fda #chile #colombia #mexico #peru
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