Electronic Quality Management System Software Partners

With many medical device companies electing to utilize an electronic quality management system platform, there are no shortage of software providers in the industry today. Fortunately, Kapstone has evaluated many of these providers and can assist with creating a new QMS or transitioning an existing QMS to an electronic platform. Our own QMS is electronic-ready and currently in use by many of our clients.

We primarily partner with a select handful of software companies. If you’ve determined that an eQMS is the right fit for your organization and would like to see a demo by Kapstone or one of our primary partners, please reach out to us directly.

Our eQMS software partners include:

Development Partners

For product development projects where electrical engineering, software engineering, or specific technical expertise is required, Kapstone collaborates with engineering partners to assemble a team with all the necessary capabilities. We act as the project manager, maintaining a seamless working environment in which our technical resources operate alongside our partners’.

We regularly partner with:

Testing Partners

For most early tests of new product design, Kapstone will internally conduct evaluations at one of our facilities. For more stringent tests, including those for regulatory submissions, Kapstone employs a variety of appropriately accredited third-party facilities. This may include activities for:

This may include activities for:

• Mechanical testing
• Electrical testing
• Cadaveric testing (facilities nationwide for easy access)
• Animal testing (US and OUS)
• Human testing (including both human factors testing and clinical testing)

Manufacturing Partners

Through our subsidiary Kapstone Manufacturing, we offer complete prototyping and production services for virtually every method and process needed for medical device manufacturing. We can seamlessly integrate this service into new product development (NPD) projects. For products Kapstone did not develop, we can still offer very competitive quotes and can manage the entire supply chain. Visit the Kapstone Manufacturing website to contact our team about your manufacturing needs.

New Partner Opportunities

Kapstone Medical is open to expanding our network of trusted partners and suppliers. If you are in the business of product testing, quality management systems (including electronic platforms), manufacturing, sterilization, packaging, or other medical device services, reach out to us to discuss a mutually beneficial relationship. Please note Kapstone is highly selective and seeking partners with a unique value add.