Medical Device Consulting That Gets You To Market


Product Design & Development

We help medical device companies create value by developing new technologies and novel products. We do this by providing you with end-to-end solutions delivering:

  • Flexibility for all types of projects
  • Cost-effective programs
  • A global team of engineers
  • A proven track-record at completing projects on time and on budget

Quality Assurance

An effective Quality Management System (QMS) is a key ingredient to your value creation process and sustainable success. Kapstone can assist you at any time, no matter where you are in your life-cycle. We can work within your existing quality system, or if needed, Kapstone can design and implement a QMS for you. We are ready to:

  • Assign a team of experts to develop your QMS
  • Provide you with a turnkey digital platform
  • Ensure that your documents & SOPs are up-to-date
  • Train your in-house engineers and managers
  • Get you ready for a potential audit

Regulatory Affairs

Expertise & experience drive successful FDA submission processes. Kapstone possesses both. Our team can prepare and submit 510(k) documentation on your behalf to address FDA requirements and anticipate potential questions, leading to on-time and on-budget regulatory approvals timelines. Partner with us and we’ll:

  • Provide you with an experienced team of experts
  • A direct communication line with regulatory bodies
  • Ensure compliance with all regulations

Intellectual Property

An effective IP strategy is a direct extension of your overall strategy. Intellectual Property protection has an enormous impact on the value of your technology. Our IP team will:

  • Help you orchestrate your IP strategy
  • Provide you with IP Insight that Tracks Product Development
  • Make a Predictable IP Investment
  • Maximize the value creation potential of your technology

Manufacturing Solutions

Partner with Kapstone and we’ll negotiate a supply arrangement on your behalf with first-in-class FDA-compliant medical device manufacturers with a proven track record with our organization. We’ll also develop for you:

  • Supply strategies
  • Negotiate contracts for purchases of raw materials & packaging needs
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