MEDIcept Inc.

Did you know that October is national Cybersecurity Awareness Month? MEDIcept Inc. has a team full of Cybersecurity experts who would be glad to help assist with your cyber needs. Contact us today at sales@medicept.com to learn more about our cybersecurity offerings. #cybersecurity #cyber #security #awareness #october #qualityengineering #software

Attending the upcoming MedTech Conference in Toronto? So is MEDIcept Inc.! Our VP of Commercialization, John Z., will be in attendance at this event October 15-17th in Toronto, Canada. To learn more about the event, click below. https://lnkd.in/djbH_24 John would love to meet with you to discuss how MEDIcept is the right fit for your company. To set up a pre-arranged meeting, email him today at sales@medicept.com. #MedTech #MedicalDevices #Toronto #Conference #Networking

MEDIcept Minute: Medical Device Sterilization Town Hall - Sterilization Short Topics and Open Q&A Sterilization is a critical component of medical device manufacturing, ensuring patient safety and preventing infections. On October 9, 2024, the FDA will host its next Medical Device Sterilization Town Hall, covering topics such as Predetermined Change Control Plans and offering an open Q&A session. This event is an excellent opportunity for medical device manufacturers, regulatory professionals, and stakeholders to gain valuable insights into current sterilization methods and emerging regulatory changes. With the FDA’s commitment to reducing reliance on Ethylene Oxide (EtO) while ensuring the integrity of the device supply chain, it's more important than ever to stay informed about evolving sterilization technologies. Don’t miss this chance to engage directly with FDA experts and ensure your devices meet the highest safety standards. Click below to learn more about how you can attend the webinar. https://lnkd.in/e-r9fjiy For more information on navigating these updates, contact MEDIcept at sales@medicept.com for expert support in regulatory compliance! #MedicalDevices #Sterilization #FDARegulations #EthyleneOxide #PatientSafety #RegulatoryCompliance 

It was great catching up with our friends at Pure Global last week in Long Beach. Email us today at sales@medicept.com to learn how our strategic alliance benefits you! #Alliance #MedicalDevices #PureGlobal #International #RAPS

That’s a wrap on the 2024 BIOMEDevice Concerence in Boston! MEDIcept Inc. was represented by several of our Associate Consultants, as well as President, F. David Rothkopf, who attended as a speaker. In addition, Associate Consultant, Brian Siroka, joined former MEDIcept Managing Director and VP, Kim Trautman, as a speaker in her session. MEDIcept will be represented at the upcoming BIOMEDevice conference this November in Silicon Valley. To set up a meeting with us at this event, email sales@medicept.com today. #MedicalDevices #Biomedical #Conference #ConferenceSpeaker #Boston #SiliconValley

MEDIcept Minute: FDA Issues Draft Guidance on Chemical Analysis for Medical Device Biocompatibility Exciting news for the medical device industry! Last Thursday, September 19th, FDA released a new draft guidance aimed at standardizing chemical analysis for biocompatibility assessments. This guidance provides essential recommendations to improve the consistency and reliability of chemical testing in premarket submissions, helping manufacturers demonstrate device safety more efficiently. The FDA is currently seeking industry feedback on the draft until November 18, 2024. This is a great opportunity for manufacturers to review the proposed approaches and contribute to shaping the final guidance. Ensuring compliance with FDA recommendations is critical to avoid delays in product approvals. Click the link below to read more about this new guidance. https://lnkd.in/gUBvBd-C MEDIcept Inc. specializes in biocompatibility assessments and regulatory compliance. Let our experts guide you through the FDA's latest draft guidance and streamline your premarket submissions.  Reach out to us today at sales@medicept.com! #MedicalDevices #FDACompliance #Biocompatibility #RegulatoryAffairs #HealthcareInnovation 

MEDIcept Minute: New FDA Draft Guidance – Conducting Clinical Trials with Decentralized Elements Get ready for the future of clinical trials!  Last week, the FDA issued its final guidance on “Conducting Clinical Trials with Decentralized Elements,” a significant step in modernizing clinical trial design. This guidance outlines key recommendations for sponsors and investigators, allowing clinical trial activities to take place remotely, such as telehealth visits and in-home assessments. By incorporating decentralized elements, clinical trials can now be more accessible, enhance participant convenience, and expand diversity in patient populations. The decentralized approach is particularly beneficial for researching rare diseases or for patients with limited mobility. Learn more about this final guidance document at the link below. https://lnkd.in/eR_4SVmj If you’re looking to implement decentralized elements in your clinical trial, MEDIcept Inc. is here to help. Contact us today at sales@medicept.com to discuss your clinical trial needs! #ClinicalTrials #FDAUpdates #DecentralizedClinicalTrials  

2024 RAPS Convergence ☑️ The MEDIcept team enjoyed talking with current and potential clients, industry experts and professionals, and more. We hope everyone knows how they can “Speed into Success with MEDIcept”! Shout to the Regulatory Affairs Professionals Society (RAPS) for putting on another great event! We look forward to connecting with everyone in May in Brussels, Belgium at the RAPS Euro Convergence. 🇧🇪

Reminder: Don’t Miss the MEDIcept Team at BIOMEDevice Boston! We’re excited to announce that MEDIcept Inc. President, F. David Rothkopf, will be speaking at the upcoming BIOMEDevice Boston Conference! In addition to David’s presentation, several members of the MEDIcept team will be attending, and we can’t wait to connect with you! This event takes place on September 25-26th with David’s session starting at 10am on the 25th. David will speak on "FDA Observations to Lifecycle Risk Processes". Stop by David’s session or connect with our team throughout the event to discuss your medical device needs. We’re looking forward to insightful discussions and networking opportunities! Can’t make it? Reach out to us at sales@medicept.com to learn more about how we can assist you. #MedicalDevices #FDA #RiskManagement #RiskProcesses #ConferenceSpeaker #Boston #Networking 

Our RAPS team is ready to meet you today! Stop by booth 626 during exhibit hall hours. #RAPS #MedicalDevices #RegulatoryAffairs #LongBeach