MEDIcept Inc.

Exciting News: David Rothkopf Interviewed by MD+DI Our President and Founder, F. David Rothkopf was recently interviewed by MD+DI to showcase his expertise with startups in the medical device industry. He shares why many medical device startups struggle—not due to a lack of innovative ideas, but from missing key regulatory, clinical, and reimbursement strategies. Additionally, he emphasizes the need for real solutions to real healthcare challenges. Read the full interview at the link below. https://lnkd.in/eRfw4gqS David will expand on this during his MEDevice Silicon Valley session on Nov. 20. If you’re attending, don’t miss his talk! If your team needs support, contact MEDIcept Inc. today at sales@medicept.com to ensure your innovations are strategically positioned for market success. #MedicalDevices #MedTech #Startups #HealthcareInnovation #RegulatoryAffairs #ClinicalStrategy #MEDevice 

MEDIcept Inc. is excited to announce that we will be in attendance at the upcoming MEDevice Conference in Silicon Valley! The event takes place November 20-21st at the Santa Clara Convention Center. MEDIcept's President F. David Rothkopf and Senior Software Quality Engineer Gregg V., will attend the conference as speakers. For more information on the event, see the link below. https://lnkd.in/gfzV7n7r Stay tuned in the coming weeks as we highlight each of our speakers and their respective sessions. If you're attending the event, email us today at sales@medicept.com. David and Gregg would love to meet with you! #MEDevice #MedicalDevices #ConferenceSpeaker #SiliconValley #SantaClara

FDA Inspections don't have to be a horror story! Is your company ready for the "trick or treat" of a regulatory inspection? Avoid the fright of an FDA warning letter with MEDIcept’s experienced team by your side. We’ll guide you through the complexities of compliance, ensuring that the only things giving you chills this season are the Halloween decorations! Contact us today at sales@medicept.com.   #FDAInspections #Compliance #RegulatorySupport #MEDIcept #HalloweenFun #HappyHalloween

WEBINAR ANNOUNCEMENT - Future Proofing Device Changes: Key Insights from the 2024 PCCP Guidance MEDIcept Inc. is excited to share that we will publish a FREE Regulatory webinar next Wednesday, November 6th at 10:00am EST. The webinar will be posted on our LinkedIn and YouTube pages. This webinar will discuss the introduction of PCCPs from the 2022 Food and Drug Omnibus Reform Act (FDORA) as well as the new 2024 Draft Guidance "Predetermined Change Control Plans for Medical Devices". The 2024 updates reflect the FDA's current thinking for a streamlined process for managing changes to medical devices. Jean-Marie Toher, MEDIcept Regulatory Consultant, will lead this webinar, with insights from our Senior Director of Regulatory, Richelle Helman. Do you have questions about how the 2024 PCCP Guidance might impact your regulatory company? Contact us today at sales@medicept.com. #RegulatoryAffairs #MedicalDevices #FutureProofing #PCCP #Guidance #Webinar

MEDIcept Insight: Cybersecurity Post-Market Surveillance Have you ever wondered how Post-Market Surveillance ties into medical device safety and cybersecurity risk management? If so, you’re in the right place! In honor of Cybersecurity Awareness Month, MEDIcept Inc. Senior Software Quality Engineer, Gregg V., Continues his series on Cybersecurity in Medical devices by diving into the topic Post-Market Surveillance. To read the final Insight in the series titled “Cybersecurity in Post-Market Surveillance”, click the link below. https://lnkd.in/e-WZiUUa MEDIcept has a team of experts who stand ready to assist in your medical device, cybersecurity, and post-market surveillance needs. Contact us today at sales@medicept.com to learn more. #cybersecurity #cyber #postmarketsurveillance #PMS #cyberpms #medicaldevices

MEDIcept Insight: Controlling Medical Device Cybersecurity Risk Have you identified possible cybersecurity threats within your medical device? Are you curious on how to control those risks? This MEDIcept Inc. Insight is filled full of information crafted just for you! MEDIcept Senior Software Quality Engineer, Gregg V., continues his “Cybersecurity in Medical Devices” series in this Insight titled “Controlling Medical Device Cybersecurity Risk”. To read the paper, click below. https://lnkd.in/eUHpDz2A Stay tuned next week as the final paper in this series in honor of Cybersecurity Awareness Month will be released. For more information about medical device cybersecurity risk controls or assistance with your cybersecurity risk management needs, contact MEDIcept by emailing sales@medicept.com #cybersecurity #riskcontrol #cyber #software #riskmanagement #medicaldevices #quality

MEDIcept Inc. is excited to announce that we will be in attendance at the upcoming MEDICA Trade Fair! We're exhibiting in collaboration with our alliance, Pure Global, and can be found at booth F18-3 in Hall 15 of the US Pavilion. For more information and to register, see the link below. https://lnkd.in/djF85sP If you're attending the conference, we would love to meet with you! Send us an email today at sales@medicept.com to set up a virtual meeting to learn more about our services and FDA expertise. #MedicalDevices #MEDICA #Dusseldorf #Clinical #Quality #Regulatory #Engineering

MEDIcept Inc. is set up and ready to see you in Boston at the Outsourcing in Clinical Trials New England Conference! If you're attending, make sure to stop by booth 14a during exhibit hall hours. To secure time to meet with us at the event, email sales@medicept.com. #ClinicalTrials #Clinical #Conference #OCT #MeetWithUs #CRO

MEDIcept Insight: Threat Modeling for Medical Devices Is your mind filled with questions about Threat Modeling and how it relates to Medical Devices? You’re in the right place! In honor of Cybersecurity Awareness Month, MEDIcept Inc. Senior Software Quality Engineer, Gregg V., continues his series on Cybersecurity in Medical Devices in this Insight titled “Threat Modeling for Medical Devices”. To read the MEDIcept Insight, click below. https://lnkd.in/eWeGNukh To further explore threat modeling and learn about other tools that can be applied to your Software in a Medical Device or Software as a Medical Device, contact MEDIcept at sales@medicept.com. #cybersecurity #threatmodeling #cybersecurityawarenessmonth #cyber #software #qualityengineering #quality #medicaldevices

REMINDER: MEDIcept to exhibit at OCT New England! If you're attending the Outsourcing in Clinical Trials Conference this week in Boston, make sure to stop by our booth, 14a. Our team can't wait to meet you! Whether you're attending the conference or not, we encourage you to set up a meeting with us by emailing sales@medicept.com to learn more about our Clinical services. #ClinicalTrials #Clinical #OCT #NewEngland #Boston