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CAPABILITIES

QMD solves each of our clients needs by providing a comprehensive approach backed by our team of experienced professionals. Our process fosters collaboration and innovation to ensure we not only understand the core needs of our clients, but also to help them thrive.

Product Design and Development

Whether it's just an idea, a napkin sketch, or an existing product that is looking to be enhanced, we have the extensive experience necessary to get it done.  QMD utilizes Solidworks 3D CAD modeling design software to achieve your vision.  We can completely design your product.  As part of the development cycle we can execute all aspects of the process from start to finish.  This includes, but is not limited to:

  • Patenting your device

  • Renderings of product concepts

  • Prototype builds

  • Finalizing production level specifications for manufacturing

  • Risk analysis

  • Cleaning and sterilization

  • Complete product testing

  • Sterile and non-sterile packaging

  • Regulatory compliance and submissions

  • Provide a complete design history file for each project

Our internal team along with an extensive network of vendors from years of being in the medical device industry will take your product from the concept stage through commercialization.

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Quality Systems & Audits

We specialize in creating, refining, and maintaining medical device quality systems that meet applicable internal, domestic, and international regulations including US 21 CFR 820 (QSR), ISO 13485, MDD, etc.  We assist our clients in identifying and resolving non-conformances to ensure products are manufactured in compliance with their quality management system.  We can execute internal audits, supplier audits, and prepare your company for compliance audits.

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Regulatory Affairs & Submissions

QMD can help navigate the regulatory pathway through domestic and international submissions for Class I, Class II 510(k), and CE Marking per the Medical Device Directive.  We can support and manage both technical file preparation and 510(k) submissions for approval.

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Manufacturing

QMD has worked together with manufacturing sites all over the world including the United States, Europe, Asia, and other areas as well.  Based on our experience and partnerships, we can help you find the right vendor to make your products.  This includes machining, stamping, injection molding, casting, and more. 

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Due Diligence

QMD has extensive experience evaluating companies and products for potential acquisitions.  We have the capability to analyze product designs, quality systems, and evaluate potential investment risks.

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Surgeon Collaboration

Our engineering group is well versed in working directly with surgeon teams to develop the design and ensure the desired product meets all expectations both clinically and mechanically.  This includes organizing and completing cadaver labs, observing surgeries in the O.R., and animal labs.

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©2017 by QMD Consulting

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