MEDIcept Inc.

MEDIcept White Paper: “Auditing 101 – Part 3: Prepare, Conduct, Host, & Respond – Navigate for Success”    Get ready for the third installment of our Auditing 101 series: "Prepare, Conduct, Host, & Respond – Navigate for Success." Building on our previous discussions about the principles of medical device auditing and constructing a robust audit management process, this article dives deeper into the essential workflows for auditors and auditees. Learn how to effectively conduct, prepare, and manage audits or inspections while addressing their outcomes.  We'll explore systematic methods, including the "Front & Back Room" approach, to enhance your audit management process and ensure continuous improvement within your Quality Management System.  Don't miss out on these valuable insights to help your organization maintain compliance and achieve audit success. Join us as we continue our journey toward excellence in quality management and regulatory compliance. To read the White Paper written by Quality Systems Consultant, Jeff Groskopf, click the link below.  https://lnkd.in/efirk8ur Reach out to MEDIcept Inc. today at [email protected] to enhance your audit process and ensure regulatory compliance with expert support! #Auditing #MedicalDevices #WhitePaper #QMS #QualityManagementSystems  

MEDIcept Minute: Upcoming FDA Workshop – Expansion of Accreditation Scheme for Conformity Assessment (ASCA) program Exciting news for the medical device industry! The FDA is hosting a public workshop on November 6, 2024, at the FDA White Oak Campus in Silver Spring, MD, and via webcast. This workshop will discuss the expansion of the Accreditation Scheme for Conformity Assessment (ASCA) program to include chemical analysis to support biocompatibility of medical devices. It’s a must-attend event for manufacturers and professionals in the medical device field involved in analytical chemistry testing and toxicological risk assessment. Register by October 30, 2024, to secure your spot.   For more information on this workshop, click the link below. https://lnkd.in/eb2n3SYv For more details on how to improve your device's biocompatibility efforts, contact MEDIcept Inc. today at [email protected]. #workshop #medicaldevices #biocompatibility #riskassessment #FDA

Hot News: New Manufacturer’s Declaration Template for Regulation (EU) 2024/1860 Released by MedTech Europe! Exciting News for In Vitro Diagnostics Manufacturers!  MedTech Europe has just released a template Manufacturer’s Declaration to help manufacturers comply with Regulation (EU) 2024/1860. Published on July 17th, 2024, this template covers the extended transitional periods, validity of certificates under Directive 98/79/EC (IVDD), and compliance for Legacy Devices. Manufacturers can easily declare their compliance using this comprehensive tool, which includes a text part and a device schedule. The template can be used by any IVD manufacturer or their authorized representative. Access the template at the link below. https://lnkd.in/eEDbkFjM For personalized assistance, contact MEDIcept Inc. today at [email protected]!   #MedTech #IVDR #Compliance #Regulation2024 #EU

Hot News: Revised Final Guidance from FDA, “Application User Fees for Combination Products,” now available! Are you navigating the complexities of application user fees for combination products? Exciting news! Yesterday, July 16th, 2024, FDA released the updated final guidance on Application User Fees for Combination Products, replacing the 2005 version. This revised guidance aligns with current user fee programs and incorporates provisions from the FD&C Act (section 503(g)). It clarifies that combination products submitted with a single application should be subject to the relevant user fee for that application type. The document also outlines the user fee application process for combination products with separate applications for constituent parts. To navigate this guidance effectively, it is recommended to refer to the Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products, along with the appropriate medical device user fee amendments (MDUFA) guidance. Click the link below to read the complete guidance from FDA. https://lnkd.in/eCdMTPe9 Stay informed and optimize your approach to managing user fees for combination products with this essential resource! For tailored assistance and expert guidance on application user fees for combination products, reach out to MEDIcept at [email protected] for personalized support. #FDA #CombinationProducts #RegulatoryCompliance #HealthcareRegulations 

Hot News: AI ACT published in the EU Official Journal! The AI Act has officially been published in the EU Official Journal, marking the beginning of its implementation phase. This new regulation is set to significantly impact the medical devices and in vitro diagnostics industries, especially for companies incorporating AI systems. Key dates include August 2, 2024, for general provisions and prohibited practices, August 2, 2025, for high-risk AI systems, and August 2, 2026, for full compliance. Ensure your AI systems meet the new standards to avoid major setbacks. For AI-focused guidance and support, contact MEDIcept at [email protected] today. Click below to read the AI Act.  https://lnkd.in/euGfjvqx #AIAct #medicaldevices #invitrodiagnostics #Medicept #AIRegulation #EU #EuropeanUnion

Are you looking for assistance in the areas of cybersecurity, artificial intelligence, or risk management? You’re in the right place! Our experienced quality engineering team stands ready to assist with your medical device, cybersecurity, risk management, AI needs, and MORE! Contact us today at [email protected] to learn how MEDIcept Inc. can help you! #qualityengineering #riskmanagement #artificialintelligence #AI #cybersecurity

MEDIcept Minute: Upcoming FDA Webinar on In Vitro Diagnostic Products (IVDs) – MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Compliant Requirements Earlier this year, on May 6th, the FDA issued a final rule amending their regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including when the manufacturer of the IVD is a laboratory. In addition, the FDA outlined a policy to phase out its general enforcement discretion approach to LDTs. This will take place over the course of four years. The FDA has recently announced a webinar to provide information on how to comply with medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements, as they relate to compliant files beginning on May 6, 2025 (stage 1 of the phaseout policy). The webinar is slated to take place on Thursday, August 22nd, from 1:00-2:30pm ET. For more details and add it to your calendar, see the link below. https://lnkd.in/eDTEVdM7 MEDIcept Inc. is your one-stop-shop for medical device consulting needs related to IVDs, MDR requirements, regulatory affairs, quality systems, and MORE! Contact us today at [email protected] to learn how we can help you. #medicaldevices #webinar #quality #regulatory #IVD #FDA 

We can't believe that 2024 is already halfway over. Whether the year has flown by or been on the slower side for your company, it's important to have a strong finish to the year! MEDIcept Inc. stands ready to assist with your company and its medical device consulting needs. Our team is full of experienced Clinical, Regulatory, Quality, and Reimbursement/Compliance consultants who would love to help your company finish out the year on the right foot. Check out our "About Us" brochure to learn more about who we are as a company and the services we offer. Then, email us at [email protected] to set up a call with the team. #medicaldevices #clinical #regulatory #qualitymanagementsystems #QMS #qualityengineering #reimbursement #compliance

Happy Independence Day from MEDIcept Inc.! #IndependenceDay #FourthOfJuly #Celebrate

Hot News: Revised Version of the MDCG Guidance on Standardisation for Medical Devices, Now Available! Exciting news! The revised and improved version of the MDCG guidance document "MDCG 2021-5 Rev.1 - Guidance on standardisation for medical devices - July 2024" has been officially endorsed by the MDCG and is now accessible on the European Commission EU Health and Food Safety DG SANTE webpage. This updated version includes new sections on the rulings of the Court of Justice of the European Union, the European Pharmacopoeia, and Common Specifications, offering a comprehensive reference on various aspects of standardisation in support of EU Regulations on Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR). For detailed insights and practical guidance, check out the document directly via the link below. https://lnkd.in/dFZQMK5Y For further information and assistance, contact MEDIcept at [email protected] for expert support and guidance in navigating the standards landscape in the medical devices sector. #MDCG #Standards #MedicalDevices #EU #Regulations #MDR #IVDR #Standardisation #EuropeanCommission #Healthcare #Guidance #MedTech