MEDIcept Inc. is excited to announce that we are exhibiting at the upcoming Outsourcing in Clinical Trials Conference! The event takes place October 23-24th in Boston, MA. To learn more about the event, see the link below. https://lnkd.in/g6BcA8qh If you're attending the conference, make sure to stop by and see our team at booth 14A! We would love to talk to you about our experience in Clinical Trials and why you should trust us for your next one! To set up a pre-arranged meeting with a MEDIcept Inc. team member at OCT, email us today at [email protected]. #ClinicalTrials #Clinical #OCT #NewEngland #Conference #Exhibitor #Attendee #MedicalDevices
MEDIcept Inc.
Business Consulting and Services
Boston, MA 11,826 followers
Global Medtech Clinical, Regulatory, Reimbursement, Compliance & Quality Consultancy
About us
MEDIcept strives to provide our clients with proven, trusted, and cost-effective solutions. We are an international medical device, IVD, combination product, and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost-effective Regulatory, Quality, Clinical, Auditing, and Educational services. Our experienced team of former FDA, Notified Body, and industry experts will work with you to efficiently develop or remediate a quality system, create a regulatory strategy, or establish a clinical trial, to meet your specific needs. MEDIcept will help you navigate the complex FDA and international regulatory pathways, reduce business risk, and decrease time-to-market while maximizing your potential for success. Every client and every issue is unique. We customize our solutions to fit your needs. With a retention rate of over 90%, we can promise that you will benefit from working with us.
- Website
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http://www.medicept.com
External link for MEDIcept Inc.
- Industry
- Business Consulting and Services
- Company size
- 11-50 employees
- Headquarters
- Boston, MA
- Type
- Privately Held
- Founded
- 1996
- Specialties
- Clinical, Regulatory, Quality, Engineering Support, Clinical Research Organization, Regulatory Submissions, Global Regulatory Strategy, Audits, Quality Management Systems, Risk Management, ISO 13485, FDA, Invitro Diagnostic, Medical Device, Remediation, Validation, Software, MDSAP, Design Control, Training, CAPA, Due Diligence, Interim Professionals, Cybersecurity, 483/Warning Letter Response, MDD/MDR, Regulatory Registration, and CRO
Locations
Employees at MEDIcept Inc.
Updates
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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 [email protected] to learn more about our cybersecurity offerings. #cybersecurity #cyber #security #awareness #october #qualityengineering #software
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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 [email protected]. #MedTech #MedicalDevices #Toronto #Conference #Networking
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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 [email protected] for expert support in regulatory compliance! #MedicalDevices #Sterilization #FDARegulations #EthyleneOxide #PatientSafety #RegulatoryCompliance
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It was great catching up with our friends at Pure Global last week in Long Beach. Email us today at [email protected] to learn how our strategic alliance benefits you! #Alliance #MedicalDevices #PureGlobal #International #RAPS
Wrapping up an unforgettable RAPS Convergence 2024 in Long Beach! We had an amazing time meeting industry leaders, exchanging ideas, and discussing the future of regulatory affairs. A special shoutout to our friends at MEDIcept Inc., whom we had the pleasure of catching up with during the conference. In case you missed it, Pure Global has recently formed a strategic alliance with MEDIcept, a leader in US and EU regulatory, quality, and clinical services. Together, we’re streamlining global market access for the medical device and in vitro diagnostics (IVD) industry, combining our expertise to help clients navigate regulatory challenges and unlock new opportunities efficiently. Thanks to everyone who stopped by our booth to say hello us! The conversations and connections made are invaluable, and we’re looking forward to what’s next! 👀 Keep an eye out for details on our next event—we’ll be announcing it soon! #RAPSConvergence #PureGlobal #RegulatoryAffairs #MedTech #IVD #MarketAccess
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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 [email protected] today. #MedicalDevices #Biomedical #Conference #ConferenceSpeaker #Boston #SiliconValley
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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 [email protected]! #MedicalDevices #FDACompliance #Biocompatibility #RegulatoryAffairs #HealthcareInnovation
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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 [email protected] to discuss your clinical trial needs! #ClinicalTrials #FDAUpdates #DecentralizedClinicalTrials
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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. 🇧🇪
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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 [email protected] to learn more about how we can assist you. #MedicalDevices #FDA #RiskManagement #RiskProcesses #ConferenceSpeaker #Boston #Networking