The growing number of chronic diseases along with the expanding geriatric population has led to a drive in research and development, increasing the trend in early disease detection and maturing the clinical diagnostic market. Despite the most popular devices belonging to the point of care (POC) category and the existence of pregnancy and glucose over-the-counter self-tests, the wide range of diagnostic devices including highly sophisticated DNA technology. This category includes reagents, calibrators, control materials, kits, software and related instruments.
Whilst outsourcing in the diagnostic devices market ranges from laboratory product development through to accompanied pharmaceutical R&D, SteriPack assists in the whole processes, starting from device design for manufacturing assessment and packaging development all the way to market delivery. SteriPack’s expansive regulatory and industry experience and established processes helps to ensure smooth transitions to meet challenges and needs.
In vitro (IV) diagnostic services at SteriPack:
- Design and development (design review, robust design, DFM, DFA)
- Cleanroom injection molding
- 3D Printing and additive manufacturing
- Sterile barrier packaging
- Process validation
- Quality and microbial testing
- Material sourcing
- Regulatory support
- CE marking
SteriPack’s contract services are designed to support Customers at every stage of product development. Both regulatory and industry experience helps to proceed smoothly through all requirements and needs.
Typical application areas:
blood test vials, allergy tests, breath monitoring devices.