Tomas V. Pla

Sterilization standards are non-negotiable for medical device manufacturers. At DP Distribution & Consulting, we help you navigate EtO and Gamma requirements with clarity and confidence. Compliance doesn’t have to be complicated—reach out for expert assistance today.https://dpdconline.com/ #Sterilization #EtO #GammaSterilization #RegulatoryCompliance #MedicalDevices #MedicalDeviceManufacturing #HealthcareStandards #QualityManagement #ProcessValidation #MedTech #DPDConsulting

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Don't sugarcoat it.  Communicate design challenges and "hard to manufacture" elements of your device with your vendors early on. They will thank you for it. Dive deep on this topic (and more) with Samantha Wagner in the full episode. Link in the comments. #medtech #innovation #supplier #medicaldevice #contractmanufacturing

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Nipro Medical Corporation are to build a $398M North Carolina plant. 👏 This facility will stabilize Nipro's U.S. supply chain, reduce transportation needs, and cut carbon emissions. It will also feature a medical training center, a customer service center and room for future expansion. Opening a new facility can be a challenging process, but with the right tools, it can also be incredibly rewarding. Our ERP software, MIE Trak Pro, is designed to streamline operations, improve efficiency, and support sustainable growth - especially during major expansions like this one! Read the full story here: https://bit.ly/3LyVvcT #MedicalManufacturing #Manufacturing #Engineering #ERP #MRP #ERPsoftware #MetalFabrication #Fabrication

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The manufacturing of medical devices is a complex process that requires high precision and stringent quality control. The industry is continuously evolving, driven by technological advancements and increased demand for innovative medical solutions. Learn more directly from our seasoned team of industry experts by following Michael Lynch, Soren Kaplan, George W E., Gabriel Mendoza and Michael Rothrock. #manufacturing #digitalmanufacturing #leanmanufacturing #industry40 #supplychain #sixsigma #leansixsigma #leanmanufacturing #digitalmanufacturing #kaizen #lean #manufacturingexcellence #manufacturingoperations #AI #artificialintelligence #digitaltransformation https://lnkd.in/g5Rw6qSt

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People don’t know what they don’t know! Get out there and educate your facility customers and surgeons on how they can elevate their patient care! Great beginning of the week in south Florida spreading the good news of robotics and collaborating with colleagues! #robotics #patientcare #educate #CORIrobotics #totaljointreplacement #elevatepatientcare #patientsfirst

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Transform your MedTech commercial operations. Watch this new video: #medicaldevices #medicaldevicesales #inventory #medtech Skip Kiil Neal Ferguson Pam Morgenstern John Kelty

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𝐅𝐃𝐀 𝐈𝐬𝐬𝐮𝐞𝐬 𝐑𝐞𝐦𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐢𝐧𝐠 𝐆𝐮𝐢𝐝𝐚𝐧𝐜𝐞 On May 10, 2024, the FDA issued a guidance document on “Remanufacturing of Medical Devices.” Remanufacturing is the processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use. The document is intended help clarify whether activities performed on devices are likely to be considered “remanufacturing” in an effort to provide consistency and a better understanding of applicable statutory and regulatory requirements. Also included are recommendations for information that should be included on labeling to help ensure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life. The document addresses activities performed on devices that are intended to be reused and maintained, discussing whether activities performed by original equipment manufacturers (OEMs) and third parties on such devices are likely considered as remanufacturing. Contrarily, the guidance is not intended to adopt significant policy changes, but to clarify FDA’s current thinking on applicable definitions, while not changing the regulatory requirements applicable to remanufacturers. Read the full guidance here: https://lnkd.in/dRFjbUU Visit AlvaMed's website for more industry news and insights. https://lnkd.in/eGrnpRdv

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Minimize costly disruptions with Tube Watch. Explore this advanced technology that leverages AI and digital twin technology to continuously monitor your X-ray systems, helping you prevent potential tube or generation chain failures before they occur. Learn more at #RSNA2024 booth 7330.

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We agree that collaborative partnership is critical to shared success where we all win, particularly the patient. Don’t miss this article on full-service outsourcing by Editor-in-Chief Sean Fenske in the latest edition of Medical Product Outsourcing, including thoughts from our CEO Gregg Tobin. #togetherwemakeithappen

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𝐇𝐞𝐲 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐫𝐞𝐩𝐬! When you reset trays and run them around? 𝐓𝐡𝐚𝐭 𝐭𝐢𝐦𝐞 𝐜𝐨𝐦𝐞𝐬 𝐨𝐮𝐭 𝐨𝐟 𝐲𝐨𝐮𝐫 𝐜𝐨𝐦𝐦𝐢𝐬𝐬𝐢𝐨𝐧𝐬. This isn't an opinion or an argument. 𝐈𝐭'𝐬 𝐚 𝐬𝐭𝐚𝐭𝐞𝐦𝐞𝐧𝐭 𝐨𝐟 𝐟𝐚𝐜𝐭. Plan accordingly. #medicaldevices

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Let’s dive into what makes this technology a game-changer for your practice. ✨ We have ongoing education and advanced applications, ensuring you and your staff are always confident in using the technology. ✨ Renuvion is the only device that is FDA-cleared for use after liposuction. ✨ The device goes beneath the surface to address the problem of loose skin directly at the source. ✨ It directly targets collagen-rich fibers resulting in rapid skin contraction, making treatments safer and more effective. These are just a few things that doctors love! Comment 🙌🏻 if you want to learn more about Renuvion. - Cassie 📩 cassie.waddell@apyxmedical.com

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In critical moments, every second counts. That's why Wrangler Instruments brings you fast, sterile, and reliable single-use instruments, pre-packaged and ready to go. No need for last-minute sterilization — just grab and perform. Trust the tools that prioritize your efficiency when it matters most!. . . . #emergencycare | #medicaltools | #sterileinstruments |#singleuseinstruments | #surgicalprecision |#healthcareheroes | #wranglerinstruments | #surgicalinstruments | #medicalsupplies

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Discover how the InstadoseVUE dosimeter's advanced motion-sensing technology and unique compliance star feature provide immediate visual confirmation that dosimeters are actively worn. Learn more about how these innovations enhance safety and accountability in your radiation safety program. Read more [link] #InstadoseVUE #RadiationMonitoring #RadiationBadge https://hubs.li/Q02NQNWf0

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How long does it take you to program infusion parameters on your pumps? The WalkMed 350VL can be programmed in just a few steps--and it retains programmed parameters to make repeat treatments simple. Learn more about why the WalkMed pump is a preferred option for patients and providers: https://lnkd.in/g3c8zAwB #AmbulatoryPumps #InfusionTherapy

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Hey LinkedIn Family, Henry David Thoreau once said, "Be true to your work, your word, and your friend." What timeless advice! In the dynamic world of medical device manufacturing and regulatory compliance, integrity is fundamental. Here at DP Distribution & Consulting, LLC®, we uphold Thoreau's principles of honesty and dedication. Whether navigating FDA regulations or guiding compliance strategies, we prioritize integrity in every aspect of our work. We've learned that staying true to our values and commitments makes us your trusted partner in regulatory excellence. Let's uphold integrity together. For insights, support, and guidance on your regulatory journey, visit us at dpdconline.com or connect with us on LinkedIn. Let’s build success on a foundation of integrity and trust. #HenryDavidThoreau #Integrity #MedicalDeviceRegulatoryConsulting #DPDC #MedicalDeviceConsultation #ConnectWithUs #MedicalDeviceManufacturing #RegulatoryCompliance #Trust #DPDConsulting

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Check out this great Webinar from our experts regarding Regulatory and Validation developments in VHP Sterilization! #vhpsterilization #validation #sterilization #STERIS #regulatorystandards

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Medical device company PhotoniCare, Inc. has secured $4.6 million in a Series B funding round and formed a manufacturing partnership with Gentex Corporation to produce its OtoSight Middle Ear Scope. The company also finalized the relocation of its headquarters from Champaign, Illinois, to Grand Rapids, Michigan: #Photonics #Imaging

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We are frequently engaged to consult with companies that seek adhesive solutions only after their part design is finalized. This approach can be costly, as many medical device materials are challenging to adhere to and often require specialized, more expensive solutions when we are not involved from the outset. We advocate for the principle of "Think Adhesives First" to help engineers avoid these pitfalls and optimize their designs for adhesive compatibility from the beginning. Read more about our perspective on this crucial design consideration. https://lnkd.in/g8y8XHpC

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