MEDIcept Inc.

Please see below for an important announcement.

Experienced with FDA Response/Remediation, MEDIcept Inc. helps medical device manufacturers navigate the complexities of responding to and resolving FDA regulation compliance issues. Our expert team helps companies navigate the complex process of addressing FDA concerns, whether they arise from inspections, warnings, or non-compliance with regulations. We work closely with your team to identify the root causes of issues, implement corrective and preventive actions, and ensure full compliance with FDA requirements. From updating design controls and manufacturing processes to enhancing quality assurance systems, we focus on delivering effective solutions tailored to meet the specific needs of your organization.  Our FDA remediation services also include the preparation and submission of necessary documentation to demonstrate that the required corrective actions have been taken. We assist with ensuring that all quality systems, manufacturing practices, and labeling are in line with FDA regulations, minimizing risk and avoiding potential recalls or penalties.  With years of experience and a deep understanding of FDA requirements, we provide guidance every step of the way, ensuring that your medical device is not only compliant but also safe for market use. Let us help you regain and maintain FDA compliance, so you can focus on bringing your innovative medical solutions to patients with confidence.  Ready to partner with MEDIcept Inc. for your FDA remediation services? Email sales@medicept.com today to learn more!   #FDA #Remediation #Response #Compliance #Regulations #MedicalDevices #QMS #Quality #QualityManagementSystems

Attending MedCon this week? So is MEDIcept Inc.! Brian Siroka is representing MEDIcept as a speaker. He will be speaking on a panel titled "Risk Management - Systems Perspective". The session takes place Thursday, April 24, 2025, at 2:25 PM – 3:55 PM EST. For more information on this event, hosted by AFDO/RAPS Healthcare Products Collaborative, see the link below. https://lnkd.in/e2Mx6qc9 Interested in connecting with Brian at MedCon to learn more about how we can assist in your risk management needs, email sales@medicept.com today! #riskmanagement #AFDO #RAPS #MedCon #conferencespeaker #speaker #medicaldevices #qualityengineering

Ensuring the reliability of your suppliers is critical to maintaining high-quality standards and compliance in the medical device industry. The MEDIcept Inc. quality team specializes in conducting thorough and detailed supplier audits to ensure that your suppliers meet industry standards and comply with regulatory requirements. Our audits assess key areas such as manufacturing processes, quality control systems, documentation practices, and overall compliance with ISO standards and FDA regulations. We use a systematic approach to identify potential risks and areas for improvement within the supplier’s operations, helping you mitigate issues before they impact your product quality or timeline. We understand the importance of selecting trustworthy suppliers in the medical device industry. Our experienced auditors work closely with your team to provide clear insights into supplier performance, offering actionable and scalable recommendations to enhance supplier relationships and streamline your supply chain. By conducting supplier audits, we ensure that your product quality remains consistent, and you maintain a strong commitment to patient safety and regulatory compliance. Email sales@medicept.com today to learn how our experienced quality team can assist in your next supplier audit.  #audit #supplier #supplieraudit #auditing #QMS #qualitymanagement #qualitymanagementsystems #medicaldevices

MEDIcept Inc. is excited to announce that we're exhibiting at the upcoming Regulatory Affairs Professionals Society (RAPS) Convergence! The event takes place May 13-16 in Brussels, Belgium. MEDIcept will be located at booth #14. For more information on the event and to register, see the link below. https://lnkd.in/dnUfQ2A8 MEDIcept would love to get a meeting on the calendar during this event. Email sales@medicept.com today to schedule a meeting to learn more about our regulatory services. #medicaldevices #RAPS #regulatory #regulatoryaffairs #Brussels #Belgium #exhibitor

MEDIcept White Paper: Risk Management Series Part 4 – Key Terms Our popular Risk Management White Paper series is back – continuing with a paper centered around all the relevant key terminology. In order to move onto the best practices for conducting a risk assessment, it’s important to clarify and understand some related terminology. This article provides a quick review of the more straight-forward terms and spends a bit more time on those that can get confusing. To read the White Paper written by Gregg Van Citters and Brian Siroka, see the link below. https://lnkd.in/eS4A9jPW Interested in learning more about how MEDIcept Inc. can assist in your medical device risk management needs? Email sales@medicept.com today! #riskmanagement #risk #quality #QE #qualityengineering #riskassessment #keyterms #whitepaper

MEDIcept Minute: Team NB News – EU AI for Medical Devices The European Association of Medical Devices Notified Bodies (Team NB) has recently updated its position paper (version 2) centered around the European Artificial Intelligence Act (AI Act). This focuses on the implementation for medical devices, as well as in vitro diagnostic medical devices (IVDs) The document aims to clarify any overlaps or misconceptions between the AI act and existing regulatory frameworks such as MDR and IVDR, while ensuring practical implementation and safeguarding patient safety and innovation. For more information, click below to read the document. https://lnkd.in/eJazpPe3 MEDIcept Inc. is here to assist with your company’s medical device artificial intelligence needs. Email sales@medicept.com today to speak with our quality engineering team. #AI #artificialintelligence #medicaldevices #QE #quality #qualityengineering

Did you know that MEDIcept Inc. specializes in conducting international audits, ensuring that your operations comply with global regulatory standards and industry best practices? Our expert team is experienced in navigating the complexities of different regulatory environments, including FDA, ISO 13485, CE marking, and other international requirements.  Whether you're expanding into new markets or ensuring ongoing compliance with international regulations, our audits are designed to assess the effectiveness of your quality management systems, manufacturing processes, and overall product safety, no matter where your operations are based. Our international audit services provide you with a comprehensive review of your global operations, identifying potential risks, compliance gaps, and areas for improvement. We support medical device companies in aligning their processes with the highest quality standards, facilitating smooth market access across borders. From preparation for regulatory inspections to maintaining compliance in multiple regions, MEDIcept is committed to helping you succeed in the global marketplace with confidence and consistency. Email sales@medicept.com today to learn more. #audit #auditing #auditor #internationalaudits #QMS #qualitymanagementsystems #quality #qualitysystems  

MEDIcept White Paper: Risk Management Series Part 4 – Key Terms Our popular Risk Management White Paper series is back – continuing with a paper centered around all the relevant key terminology. In order to move onto the best practices for conducting a risk assessment, it’s important to clarify and understand some related terminology. This article provides a quick review of the more straight-forward terms and spends a bit more time on those that can get confusing. To read the White Paper written by Gregg Van Citters and Brian Siroka, see the link below. https://lnkd.in/eS4A9jPW Interested in learning more about how MEDIcept Inc. can assist in your medical device risk management needs? Email sales@medicept.com today! #riskmanagement #risk #quality #QE #qualityengineering #riskassessment #keyterms #whitepaper

MEDIcept Inc. is excited to announce that we're exhibiting at the upcoming Regulatory Affairs Professionals Society (RAPS) Convergence! The event takes place May 13-16 in Brussels, Belgium. MEDIcept will be located at booth #14. For more information on the event and to register, see the link below. https://lnkd.in/dnUfQ2A8 MEDIcept would love to get a meeting on the calendar during this event. Email sales@medicept.com today to schedule a meeting to learn more about our regulatory services. #medicaldevices #RAPS #regulatory #regulatoryaffairs #Brussels #Belgium #exhibitor