In Vitro Diagnostic Design and Development Proces
A good regulatory submission starts with a clear intended purpose, solid supporting design, and analytical and clinical data for the market you intend to enter.
Are you experiencing challenges in getting your intended purpose right, or do you need to discuss how your IVD device can be commercialized in different markets?
Qserve provides a practical approach to all the steps of the IVD design and development process. IVDs need to comply with different regulatory requirements. Qserve helps IVD manufacturers and CDx companies in all product life cycle phases to get IVD compliance and to keep the product on the market according to IVD regulations in different countries. Complete every step in the design and development process for IVDs to get regulatory approval.
Regulatory requirements should be considered throughout the design process; however, many people still think that this is a box that needs to be ticked at the end of the design and development process, which leads to trouble. Qserve is happy to share this diagram to help explain regulatory requirements to stakeholders in your organization.
Whatever stage you are out in your product life cycle, Qserve has experts who have learned through industry experience and can support you with a practical approach. For any inquiries or to connect with a team member, please don't hesitate to contact us at info@qservegroup.com.
Download our leaflet with an overview of what regulatory requirements are needed from project initiation to commercialization.
Thank you for your interest!