Kapstone Medical provides consulting services for medical devices, focusing on product development, quality assurance, regulatory affairs, and manufacturing solutions. The company operates in the US and EU markets.

Kapstone Medical

Kapstone Medical | 1,756 followers on LinkedIn. We&#39;re a medical device focused service provider for engineering, quality, regulatory, IP strategy, and manufacturing. | Kapstone Medical partners with physician inventors and manufacturers to develop and commercialize new medical devices. We do this by providing services for design, prototyping, patenting, quality systems, and regulatory approvals. Kapstone Medical provides product development, quality management, and project management solutions to clients who value the knowledge, depth of experience, and resources that a highly capable outsource partner has to offer.

Sr. Project Manager at Kapstone Medical | Medical Device Design | New Product Development |

Josh Hilgart

International Medical Device R&D Consultant - Team Leadership

Hugues Malandain

Experienced with Quality in Manufacturing - Planning, Engineering, Control, Assurance, Auditing, Continuous Improvement & Leadership | Passionate…

Jennifer LaFever

Commercializing New Medical Devices | Kapstone Medical & Kapstone Manufacturing

Justin Rowland

Upcoming Webinar: The Importance of Integrating Regulatory Early into Product Development Join us on November 7, from 1-2:30 PM EDT for a FREE live webinar featuring our VP of Regulatory, Kara Johnson . Learn why early integration of regulatory is vital to prevent costly redesigns and expedite FDA approvals. Specifically, this webinar will help you: - Know when to involve regulatory: Understand the right stage in product maturity to initiate regulatory assessments. - Conduct a preliminary regulatory assessment: Identify classifications, map submission needs, and applicable standards. - Scope your regulatory strategy: Plan for design considerations, testing, and documentation. - Adapt as design evolves: Learn why regulatory strategies should be revisited as your product advances. - Avoid common pitfalls: See real examples of costly mistakes that could have been prevented through early regulatory planning. Register here: https://lnkd.in/eNvRzQWq

New Blog: 4 Ways a Medical Device Design Consultancy Supports and Improves Innovation We understand the complexities involved in bringing a novel medical device to market. Our latest blog discusses the benefits of partnering with a specialized medical device design consultancy to not only streamline your development efforts but also enhance innovation. We outline four key strategies we use to support OEMs: - Overcoming Internal Challenges: We tackle in-house process barriers effectively. - Producing Inspiration: Our experts ask critical questions to refine your product. - Providing Guidance: We deliver customized consultancy to sidestep generic solutions. - Properly Equipped Teams: Our team's diverse expertise ensures comprehensive development. Read the full article here: https://lnkd.in/euS4_3NQ #MedicalDevices #Innovation #ProductDevelopment

Check out our latest blog featuring Hayden Kapitan , Business Development Executive, and Kara Johnson , VP of Regulatory. They discuss the intricacies of medical device regulations, emphasizing the distinctions between regulatory assessments and strategies. Learn more on how to integrate these considerations early in product development to ensure compliance and accelerate market entry. https://lnkd.in/eX-pZGTE

We're excited to attend the North American Spine Society's 39th Annual Meeting next week in Chicago. If you'll be there, please feel free to message us so we can schedule a time to connect.

Read up on ISO 13485 certification in our blog. We discuss several common misconceptions and surprising facts about this standard for medical device manufacturers. Did you know ISO 13485 certification is voluntary? Learn about its three-year validity, the role of Medical Device Single Audit Program (MDSAP), and the distinctions between ISO 9001, ISO 13485, and EN ISO 13485 standards. At Kapstone, we offer expert regulatory consulting, ensuring regulatory compliance and elevating product quality and safety. Dive deeper into ISO standards with us. https://lnkd.in/edEeV_Yc #ISO13485 #MedicalDevices #RegulatoryCompliance #QualityManagement

Dive into the nuances of 21 CFR 820.30 - Design Controls for Medical Devices in our latest blog. In this blog, we spotlight the critical aspects of design controls, emphasizing its role in guaranteeing product safety, efficacy, and compliance within the industry. Insights such as: - Grasping the principles of 21 CFR 820.30 and its influence on medical device development. - Navigating the complexities of design inputs, outputs, verification, validation, and more. - Real-world examples and best practices to streamline compliance efforts while encouraging innovation. Understanding and implementing design controls under 21 CFR 820.30 is important for both compliance and innovation in the industry. Read this blog: https://lnkd.in/eaQpa8NC #MedicalDevices #DesignControls #Compliance

Did you know about Kapstone Medical’s history? This year Kapstone celebrates its 17th anniversary! Founded by John Kapitan in 2007, Kapstone established itself as the premier service provider in the medical device industry. With almost two decades of experience, we have successfully commercialized over 100 products through dozens of regulatory submissions worldwide. Our team of dedicated professionals showcases a unique blend of specialized expertise, enabling us to navigate the complex landscape of the medical device space. We've meticulously structured our model to ensure we're well-equipped to tackle the challenges and opportunities presented by the ever-evolving and innovating industry. We are ready to be a part of your journey towards shaping the future of medical technology! #medicaldevices #medicaltechnology

Updates from AAOS in San Francisco this week! Our time was packed with absorbing industry insights, experiencing innovative research and development, and seizing valuable networking opportunities. Leaving the show even more inspired to improve the quality of life. Did we miss you at the show? Don't hesitate to connect. Let's continue the conversation! #aaos2024 #orthopedics

Excited to share insights from our blog; FDA Q-Submissions for medical device manufacturers. Navigating the FDA regulatory landscape can be complex, especially for companies developing new technology. Our comprehensive guide breaks down the intricacies of the FDA Q-Submissions process, providing insights for manufacturers aiming for regulatory approval. From understanding the purpose of a Q-Submission to creating a compelling submission package, this blog offers practical tips and best practices to streamline the regulatory pathway. Regardless of your experience level, this resource serves as a valuable roadmap for achieving FDA approval efficiently and effectively. Full article here: https://lnkd.in/ezudvJjK

For the past 17 years Kapstone Medical has provided expert services to medical device companies, but did you know about our manufacturing related capabilities offered through Kapstone Manufacturing? Formally established in 2019, Kapstone Manufacturing supplements our product development customers with Kapstone Medical and supports standalone customers similar to how a typical contract manufacturer provides production services. We especially want to highlight our metal and plastic 3D printing services, employing an SLM 280 2.0 and EnvisionOne cDLM XLa. Our setup is perfect for launching prototyping to initial production jobs. Reach out and request a quote anytime!

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John Kapitan

Chief Operations Officer

Mike Burgan

VP of Engineering

Brogan McGuire

Director of Finance

Brenda Hilton

Senior Director of Quality

Nikhil Mangale

Director of Project Management

Sam Wakeel

Operations, Quality and Customer Service

John Virostek

Business Management

Product Development Engineer

Burl Daniel

Regulatory & Quality

Carolyn Algar

VP of Business Development

Private North Carolina Companies (Top 10K)

Medical Companies With Less Than $1M in Revenue (Top 10K)

North Carolina Companies (Top 10K)

Medical Device Companies With Less Than $50M in Revenue (Top 10K)

Kapstone Medical is a full service provider that partners with physician inventors and manufacturers of all sizes to develop and commercialize new medical devices.

Kapstone Medical offers services for design, prototyping, patenting, quality systems, and regulatory approvals. It provides product development, quality management, and project management solutions to clients who value the knowledge, depth of experience, and resources that a highly capable outsource partner has to offer. Their range of services includes all aspects of product development namely Engineering, Intellectual Property Protection, Quality Assurance, and Supply Chain Management.

Kapstone Medical is based in Charlotte, NC, USA and the company was founded in 2007 by John Kapitan.

Charlotte

North Carolina

United States

North America

MOMI Brands has raised nearly $2.1M, wants up to $10M

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Kapstone Medical offers a comprehensive approach to new product development, integrating design, engineering, regulatory affairs, quality assurance, and manufacturing to advance medical devices from concept to market.

Kapstone Medical assists in developing regulatory strategies for medical devices, addressing market requirements, risk assessments, and compliance to ensure successful commercialization.

Kapstone Medical provides quality assurance services, including quality management systems, gap analysis, and auditing, to ensure compliance with regulatory standards throughout the product lifecycle.

Kapstone Medical supports regulatory submissions for FDA and EU, helping clients prepare documentation, liaise with regulatory bodies, and navigate submission processes.

Kapstone Medical aids in developing compliance programs to detect, prevent, and remedy non-compliant activities, ensuring device safety and regulatory approval.

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Kapstone Medical