Please see below for an important announcement.
MEDIcept Inc.
商务咨询服务
Boston，MA 12,661 位关注者
Global Medtech Clinical, Regulatory, Reimbursement, Compliance & Quality Consultancy
关于我们
MEDIcept Inc. is a leading medical device, IVD, and combination product consulting firm and CRO with 3 decades of experience. We help companies, from startups to global multi-site manufacturers, navigate complex regulatory environments and achieve market access. Our expert team, with deep industry insight, provides tailored solutions, including strategic regulatory pathway development, quality management system optimization, clinical strategy, full-service in house CRO capabilities and specialized technical expertise. MEDIcept also offers compliance recovery services for addressing FDA observations and technical deficiencies. Known for our 90%+ client retention rate, MEDIcept delivers accelerated regulatory approvals, cost-effective compliance, and customized strategies aligned with client needs. MEDIcept is recognized as a thought leader in emerging fields like digital health, SaMD, and cybersecurity, offering strategic guidance and scalable solutions for business growth. MEDIcept is committed to long-term success for clients in an increasingly complex regulatory landscape. Contact us at [email protected] with your quality, regulatory, and clinical needs.
- 网站
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https://www.medicept.com
MEDIcept Inc.的外部链接
- 所属行业
- 商务咨询服务
- 规模
- 11-50 人
- 总部
- Boston，MA
- 类型
- 私人持股
- 创立
- 1996
- 领域
- 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和CRO
地点
MEDIcept Inc.员工
动态
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Catherine E Crismon, Senior Quality Systems Consultant is another one of MEDIcept Inc.’s Auditing Superstars! Catherine is a senior quality professional with over 25 years of dedicated experience specializing in internal audits. She brings a wealth of expertise in ensuring compliance with critical medical device regulations. Her certifications as a Lead Auditor for EU MDR, MDSAP, and ISO 13485, coupled with her experience as a cGMP Internal Auditor for 21 CFR 210/211 and 820, demonstrate her comprehensive understanding of quality management systems. Catherine's Key Strengths: - Extensive Internal Audit Expertise: She manages, executes, and facilitates internal audits for organizations, subsidiaries, and distribution hubs, both domestically and internationally. - Deep Regulatory Knowledge: Certified Lead Auditor for EU MDR, MDSAP, and ISO 13485. - cGMP Proficiency: Experienced in cGMP Internal Auditing, including 21 CFR 210/211 and 820. - Global Audit Experience: Conducting audits across diverse geographical locations. - Decades of Experience: Bringing over 25 years of quality experience to every project. Catherine is just one of the many experienced auditors on the MEDIcept team. Email [email protected] to learn more about how we can use our expertise to benefit your company. #medicaldevices #audit #auditing #auditor #quality #QMS #qualitymanagementsystems #expert
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Are you an IVD manufacturer curious to know what comes next under the May 2025 requirements and why you should act now? MEDIcept Inc. is here to guide you through the process!? To get started, we encourage you to read our recent and popular MEDIcept Insight written by Principal Software Quality Engineering Consultant, Gregg Van Citters, titled “High-Risk IVDs Drive Immediate Transition to IVDR”.? https://lnkd.in/es9SuKva Next, we encourage you to sign up for an upcoming webinar hosted by our partner, Pure Global. The webinar is titled “What Comes Next Under IVDR in 2025 and Why IVD Manufacturers Must Act Now” and is slated for Thursday, March 20th at 11:00am EST.? https://lnkd.in/eNAM8-cy Left with lingering questions on how these changes will impact your organization? Email [email protected] today!? #medicaldevices #IVD #IVDR #webinar
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Carolyn Russell, VP Technical Services, QARA, is next up in our auditing spotlight! She is a seasoned compliance leader with over 25 years of experience in the medical device and manufacturing industry, Carolyn's journey has taken her from leading compliance initiatives within organizations to enhancing her skills as a consultant, specializing in internal auditing. Her deep understanding of regulatory requirements and quality systems makes her a valuable asset to any company seeking to achieve and maintain compliance. Carolyn's Expertise Includes:? - Extensive Industry Experience: Over 25 years in the medical device and manufacturing sectors.? - Proven Compliance Leadership: A track record of successfully navigating complex regulatory landscapes.? - Expert Internal Auditor: Enhanced skills in conducting thorough and effective internal audits.? - Certified Quality Auditor: Certified Quality Auditor: Demonstrating a commitment to quality and adherence to auditing standards? - Lead Auditor Certifications: Certified Lead Auditor for ISO 13485, EU MDR, and MDSAP. Carolyn and her auditing team are packed with auditing expertise. Email [email protected] to learn more about how MEDIcept Inc. is the right fit for you.? #medicaldevices #audit #auditing #auditor #quality #QMS #qualitymanagementsystems #expert
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MEDIcept Inc. is eager to spotlight a few of our auditing superstars! First up is Brian Markham, Chief Quality Officer.? Brian is a seasoned professional with 30 years of deep expertise in medical device quality and regulatory management. Brian specializes in helping companies overcome serious regulatory challenges and build robust quality systems. Facing a Consent Decree, Warning Letter, Import Detention, or FDA 483 observation? Brian can help. He provides expert guidance and hands-on support to rectify issues and restore compliance. Brian's Comprehensive Auditing and Consulting Services: Expert Auditing:?? - Conducts thorough Quality Systems (QSIT), GMP, and GLP audits.? - Extensive experience in third-party certification auditing, mock FDA inspections, preventive auditing, and training audits.? - Performs Quality Systems assessments to evaluate integration, effectiveness, and consistency across multi-site organizations.? - Conducts due diligence assessments and supplier evaluations, including supplier audits.? - Proven track record of Corporate Quality System and Compliance Auditing across 25+ worldwide manufacturing and distribution sites. Specialized Expertise:?? - Provides targeted solutions for companies facing regulatory challenges like Consent Decrees, Warning Letters, Import Detentions, and FDA 483 observations.? - Offers comprehensive audit readiness training to prepare teams for regulatory inspections. Strategic Consulting:?? - Helps clients develop and implement effective corrective and preventive action (CAPA) plans.? - Provides guidance on building and maintaining robust quality management systems (QMS) that meet FDA and ISO 13485 requirements. Interested in learning more about how our quality team can assist your organization? Email [email protected] to set up a virtual meeting. #medicaldevices #audit #auditor #auditing #quality #QMS #qualitymanagementsystems #expert
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Hot EU MDR/IVDR News! Yesterday, March 12th, Team-NB (The European Association of Medical Devices Notified Bodies) released a statement titled “Certificates with Conditions – Team NB Statement”. The statement outlines the use of conditional certifications under EU MDR 2017/745 and IVDR 2017/746. In addition, the statement pinpoints how notified bodies can maintain patient safety and issue certificated with certain conditions or limitations to help support market access. For further information, view the link below, which will direct you to the Team-NB statement and press release. https://lnkd.in/eqaUZb9s MEDIcept would love the opportunity to meet and discuss how this news might impact your medical device company. To set up a virtual meeting, email [email protected]. #medicaldevices #EU #notifiedbodies #MDR #IVDR #patientsafety
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Achieving sustainable quality across global operations requires a partner with deep expertise and a commitment to excellence. MEDIcept’s Auditing Team brings a wealth of experience in conducting multi-site global assessments. MEDIcept Inc. stands ready to assist your team with an audit. In the last year alone, we have performed 100+ audits (GMP & ISO), with proven success and client satisfaction. Over the next few days, we’re excited to spotlight a few of our auditing superstars. Stay tuned to learn more about Carolyn, Brian, and Catherine; including their strengths, expertise, what makes them stand out, and more! Connect with MEDIcept to discover how their expertise can enhance your organization's compliance and operational performance. Email [email protected] today! #AuditingServices #GlobalCompliance #QualityControl #GMPAudit #ISOAudit #ContinuousImprovement #RegulatoryCompliance
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MEDIcept Insight: High-Risk IVDs Drive Immediate Transition to IVDR As the deadline for compliance with the European Union's In Vitro Diagnostic Regulation (IVDR) looms, high-risk IVD manufacturers are facing a critical challenge to meet the new requirements by May 2025. This paper explores the latest regulatory amendments and provides actionable insights on how companies can swiftly transition, including the importance of aligning with ISO 13485:2016, enhancing post-market surveillance, and addressing emerging privacy and cybersecurity regulations. With less than three months to comply, this is a must-read for any organization looking to navigate the complexities of IVDR compliance and avoid disruptions in the market. To read the MEDIcept Inc. Insight, written by Principal Software Quality Engineering Consultant, Gregg Van Citters, see the link below. https://lnkd.in/es9SuKva For more information on how MEDIcept can help your organization navigate this regulation, email [email protected] today! #medicaldevices #EU #IVDR #quality #QMS #qualitymanagementsystems #qualityengineering
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Check out F. David Rothkopf's most recent post, "Challenges with the De Novo Pathway: A Growing Concern for Innovation". Are you interested in working with a team who can help you navigate this changing landscape or various other regulatory needs? Email [email protected] today!
?? Challenges with the De Novo Pathway: A Growing Concern for Innovation ?? On January 31st, the administration issued an Executive Order that could significantly impact the FDA's approval process. The order requires that for every new regulation to be implemented, 10 existing regulations, rules, or guidance documents must be removed. The broad definition of “rules” in the order means that nearly every regulation within the FDA’s extensive list could be subject to review. While this might seem like a move to streamline and eliminate outdated regulations, it could have unintended consequences—especially on the De Novo process. The rise in De Novo applications due to technology outpacing current predicates makes this a critical issue. The De Novo pathway is a critical route for innovative medical devices that don’t have a direct predicate. Once a De Novo application is approved, special controls are created, and these special controls are considered regulations. Here’s where the challenge arises: ? For every approved De Novo application, 10 FDA regulations must be removed before approval. This leads to two main issues: ? Increased Complexity: The FDA might find it easier to push devices through the PMA (Pre-market Approval) pathway instead, rather than searching for 10 regulations to remove. ?External Impacts on Product Evaluation: De Novo applications could now be impacted by factors outside of product evaluation—specifically, finding 10 regulations to remove. This adds unnecessary uncertainty to the process. MEDIcept Inc. we have already seen an impact this month. For years we have commonly requested De novo classification using the pre-submission process or a request for designation submission. We are now being asked to send these requests through the 513G process. Not only does the 513G process cost the company money in FDA fees, but it was also not designed to provide regulatory pathways, only classifications. It is unclear if FDA is pushing companies this way to raise funds or delay things so they can find 10 old regulations before they approve the classification.?—companies face increased costs and delays. The consequences are clear: Innovation could be stifled, and new medical technologies may struggle to find their way to market. If you are navigating this changing landscape or need assistance with a new product or regulatory pathway, MEDIcept Inc. is here to help! Let’s work together to ensure that the regulatory process doesn’t hinder progress. ?? #DeNovo #FDA #Regulations #Innovation #MedTech #MedicalDevices #RegulatoryPathways #Healthcare
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MEDIcept Minute: Consultation on Medical Devices Regulations – Routes to Market and In Vitro Diagnostics Devices Hot MHRA News! Today, February 26th, the UK Government has published its response to the consultation on “medical device regulations: routes to market and in vitro diagnostic devices”. This response is part of a wider discussion, focusing on four target areas: 1)?International Reliance 2)?UKCA Marking 3)?In Vitro Diagnostic Devices (IVDs) 4)?Assimilated EU Law The response related only to the final proposal in the consultation, relating to key pieces of assimilated EU Law. Furthermore, the response addresses feedback from industry stakeholders, outlining the decision to retain vital pieces of assimilated law beyond May 26, 2025. The goal is to avoid regulatory gaps and ensure patient safety. To learn more about the four key pieces of EU law beyond May 26th and more, click the link below. https://lnkd.in/e39GeGbN Are you interested in learning how this MHRA news impacts your company? MEDIcept Inc. is here for you! Email [email protected] to set up a virtual meeting. #MHRA #hotnews #medicaldevices #invitro #IVD #invitrodiagnostics
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