Product quality
Product requirements, intended use and supporting information are considered during portfolio review.
Quality & compliance
A careful approach to healthcare products.
Vivoo Group places product suitability, applicable regulatory requirements, traceability and responsible support at the centre of portfolio and partner decisions.
Quality framework
Clear principles across the product lifecycle.
We use precise, conservative language: certification and regulatory status vary by product and manufacturing partner and must be verified through applicable documentation.
Partner selection
Manufacturing and supply partners are considered against relevant commercial and quality criteria.
Regulatory compliance
Applicable CE marking, EU requirements and product status are reviewed where relevant.
Documentation & traceability
Product, batch and supporting information are managed with traceability requirements in mind.
Complaint handling
Product feedback and complaints should be recorded, assessed and escalated responsibly.
Continuous improvement
Feedback from customers, partners and post-market activity can inform future improvements.
Regulatory wording
Appropriately qualified products and partners.
Where applicable, Vivoo Group seeks products supported by appropriate CE marking and documentation under relevant European medical device requirements.
Manufacturing partner credentials, including ISO 13485 certification where relevant, should be confirmed for the applicable product and facility. This website does not claim that Vivoo Group itself holds a certification unless formally verified.
Document centre
Prepared for future controlled documents.
Files will be published here only after internal approval. Contact the team for product-specific documentation currently available.
Certificates
Applicable certificates and scope information.
Declarations of Conformity
Product-specific declarations where applicable.
Product documentation
Specifications, instructions and supporting information.
Quality policy
Approved Vivoo Group quality policy.