MEDIcept Inc.

MEDIcept Minute: Stay Ahead with FDA eSTAR: Version 5.4 Released! FDA eSTAR Update Alert! ?Earlier this week, FDA released Version 5.4 of the eSTAR tool. Ensure your medical device submissions meet requirements by reviewing the updated version history and device description help text—critical for avoiding technical screening deficiencies. With the mandatory use of eSTAR for 510(k) submissions already in effect, and De Novo submissions required by October 2025, staying current is key. eSTAR simplifies the process with automation, standardization, and built-in forms to streamline regulatory compliance. Don’t let technical oversights delay your submission! Read more about this update from FDA at the link below. https://lnkd.in/gPnEXjgW Need expert assistance with your eSTAR submissions? Contact MEDIcept Inc. today at [email protected]?for seamless regulatory support! #FDA #eSTAR #MedicalDevices #RegulatoryUpdates?

Unlocking Success in Regulatory Compliance: POLARIS??'s Journey to FDA 510(k) Clearance with MEDIcept Consulting Experts We are excited to announce the release of our latest case study showcasing how MEDIcept guided PolarisAR Inc. through the complex regulatory landscape to achieve FDA 510(k) clearance for their groundbreaking STELLAR Knee augmented reality technology. By engaging MEDIcept’s regulatory experts early in the process, we helped streamline their submission and respond efficiently to FDA feedback, significantly reducing time to market. This collaboration not only ensured compliance but also empowered the POLARIS?? team with essential skills for future success. To dive deeper into the details of this successful partnership and learn more about the challenges and solutions, visit our website at the link below to read the full case study. https://lnkd.in/dUhYjhzT Are you navigating regulatory challenges in your innovation journey? Contact MEDIcept Inc. today at [email protected] to learn how we can support your needs! #CaseStudy #PolarisAR #MedicalDevices #FDA #CustomerSuccessStory

That's a wrap on the 2024 MEDevice Silicon Valley Conference! MEDIcept Inc. was well represented by our President, F. David Rothkopf and Senior Software Quality Engineer, Gregg V.. If you attended the conference, we hope you were able to attend their sessions and connect afterwords. If you were not in attendance but want to connect with David, Gregg, and the rest of our team, email us today at [email protected]. #MEDevice #SiliconValley #MedicalDevices #Regulatory #Quality #Software

REMINDER: Upcoming FDA Webinar: Key Updates on IVD and LDT Regulations On December 3, 2024, the FDA will host a webinar to outline critical information regarding the registration and listing requirements for In Vitro Diagnostic Products (IVDs), including Laboratory Developed Tests (LDTs). This follows the FDA’s May 2024 final rule, clarifying that IVDs are considered devices under the FD&C Act, even when manufactured by laboratories. With compliance expected by May 2025, now is the time to understand how these regulations will impact your operations. Visit the link below to learn more about how you can attend the webinar. https://lnkd.in/gdir3Ce7 Don’t miss this chance to prepare your team and ensure compliance. For personalized regulatory support, contact MEDIcept Inc. today at [email protected]. #MedicalDeviceRegulations #IVDCompliance #LDTs #FDAWebinar #RegulatoryAffairs?

MEDIcept Minute: FDA Final Guidance on 510(k) - Third Party Review Program and EUA Review Released! The U.S. Food and Drug Administration (FDA) has issued its final guidance for the 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review. This document clarifies the FDA's expectations, eligibility criteria, and processes for third-party review organizations to support streamlined reviews of 510(k) submissions and EUA requests during public health emergencies. Key highlights include: -Clear FDA expectations for 510(k) and EUA third-party reviews? -Detailed eligibility criteria and procedures for third-party review organizations? -Emphasis on quality, consistency, and conflict prevention? -Insights into compensation processes This guidance represents a significant step in enhancing efficiency and ensuring high-quality regulatory reviews. Read more about this new guidance from the FDA at the link below. https://lnkd.in/gePaN6QF Have questions or need support navigating these updates? Contact MEDIcept Inc. at [email protected] today for expert guidance. #FDA #510k #ThirdPartyReview #MedicalDevices ?

Navigating FDA Clearance: Sira Medical's Success Story with MEDIcept We are thrilled to announce the successful FDA 510(k) clearance of Sira Medical's innovative augmented reality (AR) preoperative surgical planning application! Our dedicated team at MEDIcept provided essential regulatory guidance, cybersecurity expertise, and usability testing support, ensuring a seamless submission process. This collaboration not only empowered Sira Medical with a clearer understanding of FDA requirements but also positioned them for revenue growth and future funding. To read more about this success story, visit our website at the link below: https://lnkd.in/eB76EA48 Are you navigating the complexities of FDA submissions? Contact MEDIcept Inc. today at [email protected] to learn how we can support your regulatory needs! #FDA #510k #RegulatoryAffairs #MedicalDevice #AugmentedReality #MEDIcept #SuccessStory #HealthcareInnovation

REMINDER - MEDIcept to attend MEDevice Silicon Valley Conference Attending the MEDevice Conference this week in Silicon Valley? So are we! F. David Rothkopf and Gregg V. will represent MEDIcept Inc. as speakers. To learn more about their sessions and the event, see the link below. https://lnkd.in/gfzV7n7r The conference starts tomorrow, but there's still time to schedule a meeting with our team. If you're interested, please email [email protected]. #MedicalDevices #MEDevice #Conference #Speaker #SiliconValley

Recently, our President, F. David Rothkopf, sat down with MD+DI to discuss his upcoming presentation at MEDevice Silicon Valley. To read the interview and learn more about his presentation titled "The Do's and Dont's of Medical Device/IVD Sector Early Planning for Start-Ups", see the link below. https://lnkd.in/eq2f3tzv If you're attending the conference, make sure to mark your calendars for this Wednesday, November 20th, at 10:00am to hear his presentation. For more information on how MEDIcept Inc. can assist in your medical device or IVD needs, email us today at [email protected]. #medicaldevices #IVD ##startup #regulatoryaffairs #conference #speaker #thoughtleader

MEDIcept Minute: MHRA Launches Public Consultation on Regulatory Framework for Medical Devices in Great Britain The UK MHRA has opened a public consultation on proposed changes to the regulatory framework for medical devices in Great Britain, focusing on four key areas: International Reliance, UKCA Marking, In Vitro Diagnostic Devices (IVDs), and Assimilated EU Law. These updates aim to enhance market access, streamline device traceability, and ensure proportionate oversight based on risk classifications. This is a critical opportunity for stakeholders—including manufacturers, developers, healthcare professionals, and the public—to provide feedback and help shape the future of medical device regulation in the UK. The consultation closes on January 5, 2025, at 11:59 pm, and feedback will be instrumental in drafting the forthcoming Pre-Market Statutory Instrument. Whether you’re a device manufacturer or clinician, your input could directly impact the regulatory landscape. Read more about how you can submit feedback at the link below. https://lnkd.in/da-mUgRa To understand how these changes may affect your business or products, contact MEDIcept today at [email protected] for expert guidance and support throughout the regulatory process. #MedicalDevices #RegulatoryAffairs #MHRA #MedTech #IVD #HealthcareInnovation #MedicalRegulations #UKCA #PublicConsultation?

MEDIcept White Paper: Risk Management Series – Part 3: Transferring Risks from Fault Trees to FMEAs, URRAs, and SRAs? We are excited to continue our Risk Management Series with Part 3, where we explore how to transfer risks from Fault Tree Analysis (FTA) to Failure Modes and Effects Analysis (FMEA), Use-Related Risk Assessments (URRA), and System Risk Assessments (SRA). In this article, Gregg V., Sr Software Quality Engineer, and Brian Siroka, Associate Consultant, dive into the practical steps and benefits of combining these tools for a more comprehensive risk management strategy. By leveraging the strengths of each, you ensure that critical hazards and mitigations are effectively tracked, verified, and aligned with ISO 14971.? To read the full white paper, click the link below: https://lnkd.in/en-2Cfa5 Need support with your software quality assurance? MEDIcept Inc.'s expert team is here to help. Reach out to us today at [email protected]. #SoftwareQuality #SQA #MedicalDevices #SoftwareEngineering #WhitePaper #Compliance #Innovation #QualityAssurance?