https://www.ourmedicalminds.com/home daily 1.0 2026-01-15 https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1592691635458-CS2A4L7CBX7E7XRPKLHF/medtronic+lgo+small.png https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/5d54cf61-e2b6-44a3-9973-b1fa82798a3d/bloomer+teh+logo.png https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1592685494741-AF6LV3FKO9Y6B8KSKEK5/GE+logo.png https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/988794a1-0798-4768-b968-afc403704a0a/verily-card.png https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1592685608650-A3J6PX3HQ3V51H7JQ09V/Sanofi+logo.png https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/9503c2b7-cb0c-4955-b079-6d6fef139688/artrya.png https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1592685275236-BEMUV6Y6WBQO26FTRC4M/image-asset.jpeg https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1592685207359-95CMNYSQX87BDPR6KD0N/FeatureArticleNoImage_431x312-Lrg.png https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1592685630321-CV1CE7XF96KK3JKBTI22/smith+nephew+lgo+small.jpg https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/068566dd-7b3f-4a98-89b0-e7c25358d644/SandboxAQ_Accent_Color_Black_TM_Logo.webp https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1683573650758-6IKJ1VFNPSVQ9BZDEU38/unsplash-image-6aomTW8ojbo.jpg HOME - Risk. Management Design Controls Usability SaMD QMS Software Design & Development https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1683573823396-SFWRQ57MWXW3Q5MQ19V3/unsplash-image-R6xx6fnvPT8.jpg HOME Speaker & Moderator: 2020 Software Medical Device Development Summit https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1588380066122-GUMNJRKMA756E1ZVYHIH/lets+see.png HOME Presenter: 2019 SaMD Webinar https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1593393036939-HNGQQN7YORWJGG6G9XCZ/hcp+pic.png HOME - Speaker: 2019 MedTech Summit https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1593392692989-1FS15KNQDF3YPA331X2J/image-asset.jpeg HOME - Speaker: 2019 Human Factors & User Experience for Medical Device Design https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1588427736162-0Z3K6RX9IQ0OPTTK7QH0/image-asset.jpeg HOME Speaker: 2018 FDA PDA Conference https://www.ourmedicalminds.com/our-work daily 0.75 2024-12-22 https://www.ourmedicalminds.com/about daily 0.75 2026-03-15 https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/77a1e944-a0e6-4637-8833-2c953ca14372/20210304_155103.jpg About Us - Dana Fashina Based in Boston, MA, Medical Minds was founded by Dana Fashina. An Engineering and Regulatory strategist with deep expertise in advancing software-driven and AI-enabled medical technologies in highly regulated industries. She works at the intersection of engineering, regulatory strategy, and product development, helping organizations turn complex FDA, IEC, and ISO requirements into practical development systems that allow teams to build innovative medical technologies with confidence. Known for bridging executive vision with engineering execution, her expertise lies in bridging a gap the distance between how engineers build technology and how regulators evaluate it. Dana helps companies design scalable development environments that support rapid innovation while maintaining the rigor required for defensible regulatory submissions. She’s known for spotting structural problems early, solving complex technical challenges, and building operational systems that allow innovation to scale. Her superpowers include: seeing around corners, strategic problem solving and developing efficient operations. https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1590533562880-5YW4Q3SILFIAQ9QS4VTC/Arlesa.jpeg About Us - Arlesa Hubbard Arlesa has a background in Medical Device Development with specific training in Regulatory Affairs, Risk Management, Design Controls, and Quality Systems management. She is passionate about developing safety systems and most recently has worked as a Risk Manager for a global pharmaceutical company, where she supported the development of various device technologies to assist in the treatment and/or management of diabetes and select rare diseases. In her current role, she focuses on the design & development of both combination drug-device products and standalone software as medical devices, as well as their connected ecosystems. Prior to her current position, Arlesa held roles as both Risk Management Engineer and Quality Manager for Fresenius Medical Care where she was responsible for supporting new product development and sustaining engineering activities. Arlesa holds a B.S. in Biomedical Engineering from The University of Miami, a M.S. in Regulatory Affairs for Drugs, Devices, and Biologics from Northeastern University, and a M.S. in Systems Design and Management from MIT. https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1588379815439-G0K005HIVCXJY3H62PC3/hcp+pic.png About Us - Speaker: 2019 Annual MedTech Summit Speaker: 2019 MedTech Summit https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1592684477235-U19TSI6IEOL5RHYXD85N/image-asset.jpeg About Us - S peaker: 2019 Human Factors & User Experience for Medical Device Design https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1588379883238-0FYAON17IT2ZS06SS2K6/mobile+app+photo.png About Us - Presenter: 2019 SaMD Development Webinar Presenter: 2019 SaMD Webinar https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1588379923348-DWG29S8HA7HA4ZM7RSJA/stock+photo.png About Us - Speaker: 2018 FDA PDA Conference Speaker: 2018 FDA PDA Conference https://www.ourmedicalminds.com/contact-us daily 0.75 2024-12-26 https://www.ourmedicalminds.com/across-domain daily 0.75 2024-12-22 https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1588370799386-WD4Q7QGQ7H0GY1OE02Z8/image-asset.jpeg Expertise Across Domain - New Product Development Design Feasibility Customer Needs -> Product Requirements ISO 14971 Risk Management Cloud Hosting Applications IEC 62304 & TIR45, AGILE Software Development Software Lifecycle Management IEC 62366 Human Factors & Usability Engineering Design Verification; Test Case Development & Protocol Writing Defect Management & Software Problem Resolution Design Transfer SaMD Software Development & Product Release https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1588367187724-Z28EYJ5HNIZDY7BDUP59/image-asset.jpeg Expertise Across Domain - Compliance & Regulatory ISO 13485 Quality Systems Development QMS Process Creation and SOPs Change Control IEC 62304 Software Problem Resolution Development FDA Cybersecurity Risk Management Cybersecurity SPDF and Threat Modeling AAMI TIR57 Audit Preparedness & Mock Inspection Quality Engineering Support - Product Development Teams GMP Training Compliance Gap Analysis 510k Regulatory Submissions - Strategy and Development IVDR Performance Evaluation Preparation https://images.squarespace-cdn.com/content/v1/5e979e39c280090bb99b3fc5/1588367349920-COKB30G48TVVD4Q1PQTV/image-asset.jpeg Expertise Across Domain - Testing & Production Validation Test Plan & Protocol Creation Computerized System Validation (CSV) Software Tool Qualification & Governing SOP development Process Validation Test Method Validation Kaizen Process Map Evaluation https://www.ourmedicalminds.com/across-industry daily 0.75 2024-12-22 https://www.ourmedicalminds.com/custom-404-error daily 0.75 2020-05-08 https://www.ourmedicalminds.com/what-to-expect daily 0.75 2024-12-26 https://www.ourmedicalminds.com/resource-funnel daily 0.75 2020-05-26