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Medical Systems Consult, LLC

Medical Systems Consult, LLC

医疗设备制造业

Dracut，Massachusetts 158 位关注者

End-to-end Product Design and Development. Custom Digital Health Solutions. Strategic Partnerships.

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关于我们

Medical Systems Consult is a systems engineering and product development consulting company specializing in electromechanical medical devices, IVD automation software, and digital health solutions. At Medical Systems Consult, our working model is based on a systems thinking approach with emphasis on collaborations between cross-functional business stakeholders and subject matter experts, and driven by international state of the art standards and best practices - the results are High Quality, Effective & Innovative Solutions, On-Time and On-Budget. Medical Systems Consult can partner with you to bridge any gaps in technical staffing, multi-disciplinary product development and testing, and regulatory compliance consulting. We have established a rich network of subject matter experts & associates that have a unique skill set, from product design, complex system engineering, human factors and mechanical engineering through full-stack software and interconnectivity for IOT to market access and total product life cycle management. Our associates network includes experts in combination products, connected health solutions, clinical validation, usability/human factors, former regulatory agency auditors, application specific post-market, expert review panels, safety conformity assessments and certifications, and many other fields, to help get your products to market quicker. Our specialties include: - Software Development Life Cycles for Safety-Critical Class II and III Medical Devices, meeting IEC 62304 and ISO 14971 requirements, aligning SOPs and generating complete DHF artifacts for compliance coverage. - Risk Management per ISO14971, incorporating software validation and traceability, and aligning with current FDA guidance on current topics such as cybersecurity risk management, human factors aspects, and Software as a Medical Device (SaMD) design principles. - Quality Management Systems meeting ISO 1385, 21 CFR 820 & 21 CFR 803, and Part 11.

网站
https://www.medicalsysconsult.com
所属行业
医疗设备制造业
规模
2-10 人
总部
Dracut，Massachusetts
类型
私人持股
创立
2016
领域
Systems Engineering、Risk Management、Software Development、Project Management、Embedded System Design、IEC 62304、ISO 14971、System Architecture、Regulatory Compliance和In Vitro Diagnostics

地点

  • 主要

    26 Orchard St

    US，Massachusetts，Dracut，01826

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Medical Systems Consult, LLC员工

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动态

  • ?? From Prototype to Production - Agile Development in Regulated Medical Devices What if you could accelerate your path to an optimal solution while staying fully compliant with medical device regulations? With agile development, you can: ? Rapidly iterate multiple prototypes to refine designs. ? Maintain real-time design control records and a complete documentation trail. ? Identify and solve challenges early—before they become costly delays. ? Achieve a faster path to market with quality and compliance. At Medical Systems, we collaborate with a network of specialized partners who are experts in diverse healthcare applications and domains and with their prior experience your program is accelerated and the overall risk is reduced. Let us bring your vision from concept to market faster, smarter, and with confidence. #AgileDevelopment #MedicalDevices #RegulatoryCompliance #PrototypeToProduction #Innovation #HealthcareExperts

  • Which AI Assistant App Do You Find Most Useful? We’re excited to hear from you! We want to know which AI assistant app listed on the link below in the comments you find most useful. Your feedback will help us improve and shape future innovations. It only takes a few minutes—simply leave a comment with your app of choice, and as a thank you, we'll send you a free promotional trial license for that app! We appreciate your input and look forward to your thoughts!

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  • Struggling with software and cybersecurity documentation for your 510(k) submission? Whether you need help preparing, reviewing, or addressing FDA deficiencies from an AINN letter, our team can ensure you're meeting all regulatory expectations. We also assist with quality system updates, product technical documentation, product development, and certifications. Let’s discuss how we can support your success. Contact us today!

  • Get a free adverse event report for your medical device! Head over to https://lnkd.in/e5GRY57K and enter your search criteria using our data visualizations. Download the AI configuration file and send it to us at [email protected]. We will run our AI Assistant app on your configuration file and send you a free comprehensive report with many safety trends and hidden insights to review as part of your post market surveillance. Smash that like button and subscribe for more updates on our AI Assistant app. Have a wonderful day!

  • Unlocking the Power of Systems Engineering in Healthcare At Medical Systems Consult, we leverage systems engineering to streamline every aspect of the medical device lifecycle, ensuring that the designs are safe, effective, and reliable. Here's how we do it: 1. Comprehensive Requirements Management We start by meticulously gathering and managing requirements to ensure that every stakeholder's needs are met. This sets the foundation for successful product development. Requirements definition is synonymous with problem definition, and it is the cornerstone of creating the best solution to the problem at hand. 2. Rigorous Testing and Validation Through extensive testing and validation, we ensure that the products meet all regulatory, safety and performance standards. This includes both bench testing and simulated use, replicating real-world conditions to guarantee performance. 3. Simulated Use Scenarios By employing simulated use scenarios, we can foresee potential issues and address them early in the development process. This proactive approach minimizes technical and business risks and enhances product reliability. 4. Robust Risk Management Our comprehensive risk management processes identify, assess, and mitigate risks throughout the product lifecycle. This ensures patient safety and compliance with regulatory requirements. We have even developed an agile playbook that encompases risk management activities throughout the total product lifecycle. 5. Seamless Integration Systems engineering enables seamless integration of all components, ensuring that every part works harmoniously within the larger system. This results in a cohesive, interoperable, and high-performing product. 6. Enhanced Efficiency By adopting a structured, methodical approach, we enhance efficiency and reduce time-to-market. This means faster delivery of innovative solutions that meet the well defined market needs. 7. Usability and Human Factors Engineering We prioritize usability and human factors engineering to ensure the designs are intuitive and user-friendly. This focus on the end user not only improves the user experience but also enhances safety and effectiveness in real-world applications. At Medical Systems Consult, we are passionate about applying systems engineering principles to bring cutting-edge medical devices to life. Our commitment to excellence drives us to partner with our clients to continually improve and innovate, ensuring the highest standards of quality and safety. ?? Learn more about how we can help you navigate the complexities of medical device development at https://lnkd.in/eNqvMwVT #SystemsEngineering #HealthcareInnovation #MedicalDevices #RiskManagement #ProductDevelopment

  • ?? Ensure Security Throughout Your Product Lifecycle with Our Expert Consulting Services! In today’s fast-evolving healthcare industry, maintaining a secure product development framework is paramount. At Medical Systems Consult, we specialize in integrating robust cybersecurity lifecycle activities into your Quality Management System (QMS), safeguarding your products from inception to post-market surveillance. Our services provide: ? Integrating cybersecurity SOPs, work instructions and forms within your existing design controls, purchasing, and post market processes. ? Comprehensive risk assessments to identify and mitigate vulnerabilities early in the development process. ? Tailored security solutions with custom strategies aligned with your specific product needs and regulatory requirements. ? Continuous monitoring and improvement to ensure ongoing compliance and security throughout the product lifecycle. ? Expert guidance by our experienced consultants thar stay updated with the latest industry standards and best practices. Leverage our expertise to streamline your QMS compliance with the latest cybersecurity regulatory requirements and state of the art standards. Connect with us to learn how we can enhance your QMS with a secure product development framework. ?? Visit us at https://lnkd.in/eNqvMwVT to get started. #HealthcareSecurity #QMS #ProductDevelopment #Cybersecurity #MedicalDeviceSafety

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