Electronic Quality Management System - JCeQMS

Our ISO 13485:2016 compliant and all inclusive solution to a fully electronic QMS

 

We provide your company with an electronic quality management system based on Confluence and Jira. We also provide you with a requirements workshop and training on how to use the system.

This saves you time, costs and resources in setting up a quality management system that conforms to standards, while giving you the assurance that all regulatory requirements are mapped.

Your advantages

  • All regulatory requirements are mapped, as well as traceable and transparent document control, including detailed workflows for important processes such as training, CAPA and vigilance notifications.
  • The digital linking of all documents and tasks eliminates the need for document storage. Information is also quickly retrievable and traceable.
  • The system adapts to your needs and is characterized by low running costs.

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Reasons to make use of our eQMS solution

  1. We provide you with an eQMS that serves your individual needs! Following a customer-centered approach we adapt the eQMS individually.

  2. We truly believe that regulatory knowledge is key for developing good medical devices! Our mission is to train you on the job, giving you all you need to become a regulatory expert yourself. 

  3. Your independence matters to us! We know that business continuity is essential. We offer the eQMS independently from an ongoing service level agreement

  4. Are you planning to enter the EU market? Our eQMS easily handles the complexity of EU legislation

  5. Our strength is to generate good records! Our eQMS allows you to export records in a well-structured and understandable way. 

  6. Are you looking for an external PRRC, QMR or EU representative? Combine our eQMS with our regulatory services. 

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