Mittal Consulting

🩺 Bringing your medical device to the market the first time? Looking for guidance on Regulatory Strategy/Reimbursement/Commercialization for your novel medical device? Or just want to say hi and talk about the beautiful weather in California ☀️ ⛱️ ? - Let's chat next week at the J.P. Morgan Healthcare Conference in San Francisco! #conference #medicaldevices #sanfrancisco #jpm #jpmorgan

Thanks Karandeep Singh Badwal for having me on your podcast. Appreciate your direct to the point approach and vast regulatory and industry knowledge. 𝗙𝗗𝗔 𝗔𝗽𝗽𝗿𝗼𝘃𝗮𝗹𝘀: 𝗧𝗵𝗲 𝗣𝗼𝘄𝗲𝗿 𝗼𝗳 𝗣𝗿𝗲-𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻𝘀 (𝗤-𝗦𝘂𝗯𝘀) A snippet from The Medtech Podcast Episode 74 with Kristen Mittal, RAC, PMP Founder & CEO of Mittal Consulting a seasoned expert in regulatory affairs with over a decade of experience in the field. Kristen’s expertise spans across global regulatory challenges, innovative pathways and mentorship in quality and regulatory careers. Kristen also shares insights into the evolving landscape of sectors like pediatric devices, FemTech and AI/ML in medical technology 𝗧𝗵𝗲 𝗽𝗼𝗱𝗰𝗮𝘀𝘁 𝗶𝘀 𝗮𝘃𝗮𝗶𝗹𝗮𝗯𝗹𝗲 𝗼𝗻 𝗮𝗹𝗹 𝗺𝗮𝗷𝗼𝗿 𝗽𝗹𝗮𝘁𝗳𝗼𝗿𝗺𝘀 𝗶𝗻𝗰𝗹𝘂𝗱𝗶𝗻𝗴 𝗯𝘂𝘁 𝗻𝗼𝘁 𝗹𝗶𝗺𝗶𝘁𝗲𝗱 𝘁𝗼 𝗔𝗽𝗽𝗹𝗲 𝗣𝗼𝗱𝗰𝗮𝘀𝘁, 𝗚𝗼𝗼𝗴𝗹𝗲 𝗣𝗼𝗱𝗰𝗮𝘀𝘁, 𝗔𝗻𝗰𝗵𝗼𝗿 𝗮𝗻𝗱 𝗦𝗽𝗼𝘁𝗶𝗳𝘆 𝘃𝗶𝗮 𝘁𝗵𝗲 𝗳𝗼𝗹𝗹𝗼𝘄𝗶𝗻𝗴 𝗹𝗶𝗻𝗸𝘀: Apple Podcasts: https://lnkd.in/d2F42zJT Spotify: https://lnkd.in/dpejUHxt Anchor FM: https://lnkd.in/dyQKbzAr Google Podcast: https://lnkd.in/daniXPaj Amazon Music: https://lnkd.in/gAzcqw-x Stitch: https://lnkd.in/gVvJvv_N RadioPublic: https://lnkd.in/gXcdv2MN

Applications for the 2025 MedtechWOMEN Mentorship program will open Monday, January 6 for MedtechWOMEN Members*. If you're interested in applying to be a mentee or to participate in one of the Executive Circles, renew your membership or join MedtechWOMEN before January 6 to access the application. https://lnkd.in/giYJX_3j *Eligibility to apply to the Mentorship program is a benefit of membership. Mentors are also needed! Whether you're early in your career or more experienced, your insights and knowledge in the medtech industry can provide valuable support to those navigating their own career journeys. Please consider volunteering your time as a mentor in the 2025 Mentorship Program. Click here for details and to apply https://lnkd.in/gzt8BNR3 Email us at mentorship@medtechwomen.org if you have any questions.    Read the feedback below from 2024 Executive Circle Participant, Kristen Mittal, RAC, PMP, Founder & CEO, Mittal Consulting "I really enjoyed being part of the CEO circle because of the wider perspective I’ve been able to gain. It’s comforting to hear that my colleagues and other industries are facing the same types of challenges that I am and it’s great to be able to troubleshoot some of these issues together as a team. I’ve also really enjoyed the accountability aspect of it as well and being able to really get to know each of the women in my group deeper and see familiar faces each month. It can be lonely being a CEO, with the unique challenges that we face, so it’s nice to have a support group to be a part of where we can build each other up." Kristin (Iadarola) Havranek, Nicolle Cannon, Amanda French, Roma Pérez, Catherine L., Annie Brantigan, Kate J. Stephenson, PhD, Estefi Alvarez, PhD, Angela Frederickson, Debbie Donovan, JoQuese Satterwhite, MBA, DHA, Sheila Shah, Lisa Carmel

𝗙𝗿𝗼𝗺 𝗖𝗵𝗮𝗻𝗰𝗲 𝘁𝗼 𝗖𝗮𝗿𝗲𝗲𝗿: 𝗔 𝗝𝗼𝘂𝗿𝗻𝗲𝘆 𝗶𝗻 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗮𝗻𝗱 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 A snippet from The Medtech Podcast Episode 74 with Kristen Mittal, RAC, PMP of Mittal Consulting a seasoned expert in regulatory affairs with over a decade of experience in the field. Kristen’s expertise spans across global regulatory challenges, innovative pathways and mentorship in quality and regulatory careers In this episode, we dive into why regulatory affairs is a rewarding yet complex career path, explore innovative programs like the FDA’s Breakthrough Device Designation and Total Product Lifecycle Advisory Program, and discuss the importance of harmonizing global standards in medical device submissions. Kristen also shares insights into the evolving landscape of sectors like pediatric devices, FemTech and AI/ML in medical technology 𝗧𝗵𝗲 𝗽𝗼𝗱𝗰𝗮𝘀𝘁 𝗶𝘀 𝗮𝘃𝗮𝗶𝗹𝗮𝗯𝗹𝗲 𝗼𝗻 𝗮𝗹𝗹 𝗺𝗮𝗷𝗼𝗿 𝗽𝗹𝗮𝘁𝗳𝗼𝗿𝗺𝘀 𝗶𝗻𝗰𝗹𝘂𝗱𝗶𝗻𝗴 𝗯𝘂𝘁 𝗻𝗼𝘁 𝗹𝗶𝗺𝗶𝘁𝗲𝗱 𝘁𝗼 𝗔𝗽𝗽𝗹𝗲 𝗣𝗼𝗱𝗰𝗮𝘀𝘁, 𝗚𝗼𝗼𝗴𝗹𝗲 𝗣𝗼𝗱𝗰𝗮𝘀𝘁, 𝗔𝗻𝗰𝗵𝗼𝗿 𝗮𝗻𝗱 𝗦𝗽𝗼𝘁𝗶𝗳𝘆 𝘃𝗶𝗮 𝘁𝗵𝗲 𝗳𝗼𝗹𝗹𝗼𝘄𝗶𝗻𝗴 𝗹𝗶𝗻𝗸𝘀: Apple Podcasts: https://lnkd.in/d2F42zJT Spotify: https://lnkd.in/dpejUHxt Anchor FM: https://lnkd.in/dyQKbzAr Google Podcast: https://lnkd.in/daniXPaj Amazon Music: https://lnkd.in/gAzcqw-x Stitch: https://lnkd.in/gVvJvv_N RadioPublic: https://lnkd.in/gXcdv2MN If there are any particular guests or topics you would like for us to cover in future episodes then get in touch with Karandeep Singh Badwal #RegulatoryAffairs #MedTechPodcast #MedicalDevices #AIinHealthcare #QualityStandards

🎄 Have a wonderful holiday season! Best wishes from Mittal Consulting

🌲 WORK FROM HOME is easier said than done.. Times have shifted since the pandemic and we must be nimble to balance productivity and burnout. The team has been working diligently to closely support our American and International clients 🇺🇸 🌎 . With fluctuating timelines, time zones and diverse expectations, we are immensely proud of this Mittal Consulting team to deliver excellent service for our clients to create a more sustainable business in these challenging times. Mridul Mittal Elle Winn Anthony Zhao Amanda Huynh Shu Xiang Susan Lubejko, PhD Have a wonderful holiday season everyone! ❄️ ⛄ #workfromhome #productivity #mentalhealth

Kristen Mittal, RAC, PMP, Founder & CEO of Mittal Consulting a seasoned expert in regulatory affairs with over a decade of experience in the field. Kristen’s expertise spans across global regulatory challenges, innovative pathways and mentorship in quality and regulatory careers In this episode, we dive into why regulatory affairs is a rewarding yet complex career path, explore innovative programs like the FDA’s Breakthrough Device Designation and Total Product Lifecycle Advisory Program, and discuss the importance of harmonizing global standards in medical device submissions. Kristen also shares insights into the evolving landscape of sectors like pediatric devices, FemTech and AI/ML in medical technology 𝗧𝗵𝗲 𝗽𝗼𝗱𝗰𝗮𝘀𝘁 𝗶𝘀 𝗮𝘃𝗮𝗶𝗹𝗮𝗯𝗹𝗲 𝗼𝗻 𝗮𝗹𝗹 𝗺𝗮𝗷𝗼𝗿 𝗽𝗹𝗮𝘁𝗳𝗼𝗿𝗺𝘀 𝗶𝗻𝗰𝗹𝘂𝗱𝗶𝗻𝗴 𝗯𝘂𝘁 𝗻𝗼𝘁 𝗹𝗶𝗺𝗶𝘁𝗲𝗱 𝘁𝗼 𝗔𝗽𝗽𝗹𝗲 𝗣𝗼𝗱𝗰𝗮𝘀𝘁, 𝗚𝗼𝗼𝗴𝗹𝗲 𝗣𝗼𝗱𝗰𝗮𝘀𝘁, 𝗔𝗻𝗰𝗵𝗼𝗿 𝗮𝗻𝗱 𝗦𝗽𝗼𝘁𝗶𝗳𝘆 𝘃𝗶𝗮 𝘁𝗵𝗲 𝗳𝗼𝗹𝗹𝗼𝘄𝗶𝗻𝗴 𝗹𝗶𝗻𝗸𝘀: Apple Podcasts: https://lnkd.in/d2F42zJT Spotify: https://lnkd.in/dpejUHxt Anchor FM: https://lnkd.in/dyQKbzAr Google Podcast: https://lnkd.in/daniXPaj Amazon Music: https://lnkd.in/gAzcqw-x Stitch: https://lnkd.in/gVvJvv_N RadioPublic: https://lnkd.in/gXcdv2MN  If there are any particular guests or topics you would like for us to cover in future episodes then get in touch with Karandeep Singh Badwal #RegulatoryAffairs #MedTechPodcast #MedicalDevices #AIinHealthcare #QualityStandards

Get ready for 2025 events with University Lab Partners! Understanding regulatory pathways is essential for medical device startups looking to bring their innovations to market. Join us at University Lab Partners for an in-depth session designed to help you navigate these challenges with confidence. 📅 Date: Thursday, January 23, 2025 📍 Location: Zoom 🌐 Learn more and register here: https://lnkd.in/g-pajNwQ During this session, Kristen Mittal, RAC, PMP will share: -Key regulatory pathways for medical devices, including FDA classifications and submission processes. -Strategies for compliance to minimize delays and avoid costly setbacks. -Insights into the implications of regulatory decisions for product development and market entry. 📌 Seats are limited—secure your spot today! #MedicalDevices #Startups #RegulatoryCompliance #HealthcareInnovation #Entrepreneurship

🚨 FDA just released their final guidance document for PCCP for AI enabled software!! Read the article "Exploring the Future of AI Medical Devices" below by Elle Winn from Mittal Consulting. "To add to the ambiguity, FDA notes later in the guidance that a modification in one device may not be appropriate for a modification in another device..." "With all the information about PCCPs for AI devices we’ve been provided (and not provided), it continues to beg the question: will innovators of cutting-edge medical technologies always get penalized?"

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