US FDA clearances
Selected reproductive media and cryopreservation products.
Quality & evidence
Quality systems, regulatory experience and protected design.
A concise view of the credentials, product evidence and intellectual property supporting the MediBreed portfolio.
Regulatory experience
Recognised regulatory pathways.
Selected DonneVie product families hold FDA clearances, Australian ARTG registration and CE / EU MDR certification.
Australian registration
Assisted-reproduction microtools registered for the Australian market.
CE / EU MDR
TÜV SÜD quality-system certification for sterile assisted-reproduction pipettes.
Protected product design
FlickMate & BXguard design protection.
The pipette designs are covered by registered designs or design patents in Australia, the European Union, Japan and the United States.
FlickMate
Protected pipette design with registrations across four major jurisdictions.
- Australia 202318377
- EU 015045694-0001
- Japan 1775108
- US D1,060,718
BXguard
Protected pipette design with registrations across four major jurisdictions.
- Australia 202318378
- EU 015045694-0002
- Japan 1775109
- US D1,064,313
Product documentation
Evidence available by product.
Information areaWhat we provide
SterilityMethod, assurance level and product scope
Mouse embryo assayAssay design, acceptance criterion and applicable products
EndotoxinMethod, limit and device or volume basis
TraceabilityBatch, manufacture, expiry and complaint pathway
StorageTemperature, light and transport requirements
Regulatory statusExact product, intended use and target jurisdiction
Procurement check
Request a document set for the exact model.
Tell us the model, market and intended animal workflow. We will identify the current documents available and confirm manufacturer input where needed.
- Technical drawing or specification sheet
- IFU, storage and transport conditions
- Applicable testing and batch information
- Current manufacturer and regulatory details
Quality system controls
Documented procedures behind production.
Current OEM quality procedures cover the following control areas.
Risk management
Defined review and control procedures
Design & validation
Controlled development and validation records
Traceability
Batch, manufacture and complaint pathways
Process monitoring
Production and measurement controls
Work environment
Infrastructure and environmental procedures
Nonconforming product
Documented review and disposition process
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