A good regulatory submission starts with a clear intended purpose and solid supporting design and analytical and clinical data for the market you intend to enter. Are you experiencing challenges to get your intended purpose right or do you have needs to discuss how your IVD device can be commercialized in different markets?
Qserve provides a practical approach to all the steps of the design and development process for IVDs. Learn more about our services.
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 are something you should consider 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 and this leads to trouble. Qserve is happy to share this diagram to help explain to stakeholders in your organisation how the regulatory requirements.
Download our leaflet with an overview of what regulatory requirements are needed form project initiation to commercialization.
Whatever stage you are out in your product life cycle Qserve has experts who have learn through industry experience and can support you with a practical approach.