Chairman | Electronic Product Design Expert | Speaker Wearables, IoT, Wireless, & Medical Devices | Advisor to technology startups
Documentation Compliance Support for a Startup in the Medical Device Industry https://hubs.ly/Q032wFpn0
How can you streamline medical device development while ensuring FDA and EU certifications across multiple classifications? Join our upcoming webinar to learn how Qt's powerful tools support the entire development process—from initial design to testing and post-market analytics. Using a real-world example of a medical infusion pump, we’ll showcase how Qt Design Studio, Qt Creator, and Quality Assurance tools simplify each stage. Plus, discover how Qt Insight provides critical user data after deployment. Register here: https://lnkd.in/eiY8DDaw #QtDev #Medical #MedicalDevices #HealthcareTech #SoftwareTesting
I'm In The Business Of SMILES〰Connecting Dental Companies w/ KOLs, Freelancers & Early Adopters | Training Dentists On Medical Devices | Dentist, MedTech Consultant & Board Advisor | Stubborn Optimist Who ❤️ Authenticity
𝐓𝐡𝐞 𝐓𝐡𝐢𝐫𝐝 𝐬𝐭𝐚𝐠𝐞 𝐨𝐟 𝐚 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞'𝐬 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 𝐢𝐬 𝐨𝐟𝐭𝐞𝐧 𝐭𝐡𝐞 𝐥𝐨𝐧𝐠𝐞𝐬𝐭 👇 The Verification & Validation stage is where a medical device gets put through the tests and trials of external labs/vendors. This is where the budget and time starts getting spent heavily in the development stage of a device. The Start ups I work with are surprised at how their plans start going haywire at this stage. They're often at a place where they have to keep shifting timelines because of additional tests sprouting up or delays from testing/ biocompatibility labs. "It's not going as planned" - They worry But the wait is worthwhile & essential 👉𝐄𝐧𝐬𝐮𝐫𝐞 𝐭𝐡𝐚𝐭 𝐭𝐡𝐞 𝐕&𝐕 𝐬𝐭𝐚𝐠𝐞 𝐢𝐬 𝐰𝐞𝐥𝐥 𝐦𝐚𝐩𝐩𝐞𝐝 𝐨𝐮𝐭 𝐚𝐧𝐝 𝐩𝐫𝐚𝐜𝐭𝐢𝐜𝐚𝐥𝐥𝐲 𝐩𝐥𝐚𝐧𝐧𝐞𝐝. DM me if you're planning a V & V of your dental device or had a bad experience with a previous version of your device. I can help with connecting you with the right people #medicaldevices #verification #validation
Have a read of our article below, exploring the common pitfalls to avoid when it comes to Medical Device Verification Protocols. #medicaldevices #medicaldesign #medicaldeviceverification https://lnkd.in/gvUezb9
Founder and CEO @ Medical Device Regulatory and Turnkey Project Consultant | Operon Strategist
Curious about the intricacies of medical device software validation and verification? Dive into our latest blog post to uncover the importance of ensuring safety, reliability, and regulatory compliance in the realm of medical technology. Explore the integral processes involved and gain insights into navigating this critical aspect of product development. Read more now! https://lnkd.in/eDQvDUWM Get connected: Mail ID: [email protected] Phone no: +91 9370283428 . . . #MedicalDevices #SoftwareValidation #Verification #RegulatoryCompliance #HealthTech #ProductDevelopment #MedicalTechnology #QualityAssurance #RiskManagement #PatientSafety #SaMD #medicaldevicemanufacturing #medicaldeviceindustry #healthcare #healthcareinnovations #government #medicalequipment #operonstrategist #consultation #consulting
Curious about the intricacies of medical device software validation and verification? Dive into our latest blog post to uncover the importance of ensuring safety, reliability, and regulatory compliance in the realm of medical technology. Explore the integral processes involved and gain insights into navigating this critical aspect of product development. Read more now! https://lnkd.in/efRW5CdC Get connected: Mail ID: [email protected] Phone no: +91 9370283428 . . . #MedicalDevices #SoftwareValidation #Verification #RegulatoryCompliance #HealthTech #ProductDevelopment #MedicalTechnology #QualityAssurance #RiskManagement #PatientSafety #SaMD #medicaldevicemanufacturing #medicaldeviceindustry #healthcare #healthcareinnovations #government #medicalequipment #operonstrategist #consultation #consulting
Medical Device Regulatory Consultant | Turnkey Project, CDSCO registration, Indian FDA, CE MDR , 510(k), MDSAP, SFDA, UKCA, ISO 13485, ISO 15378 | Medical Device Consultant
Curious about the intricacies of medical device software validation and verification? Dive into our latest blog post to uncover the importance of ensuring safety, reliability, and regulatory compliance in the realm of medical technology. Explore the integral processes involved and gain insights into navigating this critical aspect of product development. Read more now! https://lnkd.in/d_AxE8ts Get connected: Mail ID: [email protected] Phone no: +91 9370283428 . . . #MedicalDevices #SoftwareValidation #Verification #RegulatoryCompliance #HealthTech #ProductDevelopment #MedicalTechnology #QualityAssurance #RiskManagement #PatientSafety #SaMD #medicaldevicemanufacturing #medicaldeviceindustry #healthcare #healthcareinnovations #government #medicalequipment #operonstrategist #consultation #consulting
Healthcare Insights | Insanely Curios Thinker | Practitioner of "What If?" and "Why Not?" | Strategy Consulting | Brand Builder
There is a protocol and process for these projects - you have to know what you're doing. I enjoy them and HCPs do too since they're "hands-on". And, we can do them virtually thanks to the InterWebs and the MarketVision Research fulfillment center! #designvalidation #healthcareMRx #insights #marketingresearch MedTech Insights Forum MedTech Dive Medtech Leaders MedTech Meetup Intellus Worldwide
Medical devices need to perform consistently and reliably. Design validation is often utilized for currently marketed “legacy” medical devices classified as UOUP (User Interface of Unknown Provenance) with no design alteration that requires a full summative evaluation for FDA submission. Design validation relies on a simplified, abbreviated, simulated usability assessment process that leads to certification, while requiring adherence to developed protocols and applicable documentation standards. MarketVision Research’s experience in conducting design validations enables us to collaborate with medical device manufacturers - from simulation design and protocol development through precision execution and documentation - to ensure that each step in the process meets regulatory and manufacturer-specific requirements.
micromould, new medical mould for medium-low production and for customized components, useful for starting new experimental projects and certification of the medical device. #medical device #medical #micromould #medical #device #production #ISO 8 #project #babyplast #boy #customized #starting #ISO 13485 #conformità #automation #control
Just 3 days to go! Don’t miss this insightful webinar on Patent Protection for Software in Medical Devices & Diagnostics. Learn how to safeguard your medtech innovations with expert tips on drafting strong patent claims. Register now using the link: https://lnkd.in/dxtnd7DB or scan the QR code below! #patent #webinar #lvpei #eyehealth #software
Technical Lead at Operon Strategist | Medical Device Turnkey Project | US FDA | ISO 13485 Consultant
Curious about the intricacies of medical device software validation and verification? Dive into our latest blog post to uncover the importance of ensuring safety, reliability, and regulatory compliance in the realm of medical technology. Explore the integral processes involved and gain insights into navigating this critical aspect of product development. Read more now! https://lnkd.in/ex-VWD_Y Get connected: Mail ID: [email protected] Phone no: +91 9370283428 . . . #MedicalDevices #SoftwareValidation #Verification #RegulatoryCompliance #HealthTech #ProductDevelopment #MedicalTechnology #QualityAssurance #RiskManagement #PatientSafety #SaMD #medicaldevicemanufacturing #medicaldeviceindustry #healthcare #healthcareinnovations #government #medicalequipment #operonstrategist #consultation #consulting
