MEDIcept Inc.

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will discuss the introduction of PCCPs from the 2022 Food and Drug Omnibus Reform Act (FDORA) as well as the new 2024 Draft Guidance "Predetermined Change Control Plans for Medical Devices".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

MEDIcept Minute: FDA’s Center for Device’s and Radiological Health (CDRH) Device Trial Participation Snapshots On Tuesday, October 15th, the FDA announced that the CDRH will pilot providing device trial participation snapshots intended to give consumers and health care professionals key information related to clinical trials, supporting the FDS’s approval of new medical devices. This news comes as an overall effort by FDA to increase transparency related to clinical trials for medical products and diversity in clinical trial participation. Furthermore, it supports CDRH’s efforts to advance health equality. For more information, see the link below. https://lnkd.in/dVUi6Bb3 The CDRH is seeking comments from the public until January 13th, 2025. Are you interested in learning more about how MEDIcept can assist in your next clinical trial? Email us today at sales@medicept.com. #FDA #CDRH #MedicalDevices #ClinicalTrials #Clinical 

MEDIcept Insight: Securing Your Medical Device Software Development Life Cycle Medical device cybersecurity is more critical than ever, with FDA guidance emphasizing the importance of secure software design. In this latest MEDIcept Inc. Insight, Senior Software Quality Engineer, Gregg V., explains how manufacturers can integrate secure development practices using IEC 62304 and IEC 81001-5-1, ensuring devices meet evolving cybersecurity standards. Discover practical steps to improve your Software Development Life Cycle for safety and compliance. In honor of Cybersecurity Awareness Month, read the first Insight in the new “Cybersecurity in Medical Devices” series by clicking the link below. https://lnkd.in/dqdrn9gk For more details on how to create a secure medical device, contact Gregg and the rest of the MEDIcept team at sales@medicept.com. #Cybersecurity #MedicalDevices #SoftwareDevelopment #RegulatoryCompliance

Headed to the Outsourcing in Clinical Trials Conference next week in New England? Make sure to stop by the MEDIcept booth, 14a during exhibit hall hours. The event takes place October 23-24th in Boston, MA. If you're interested in learning more about our expertise and experience in Clinical Trials, schedule a meeting today by emailing sales@medicept.com! If you are attending the conference, we can meet in person. If not, no worries! We will arrange a virtual meeting. #ClinicalTrials #Clinical #OCT #NewEngland #Boston #Conference #Exhibitor