Product showcase
sustainability into every step of the process.
Rosti Medical Solutions
www.rosti.com
Rosti integrates cutting-edge technologies into medical devices.
focused on bringing innovation and sustainability to the medical sector. The company integrates cutting-edge technologies into medical devices and consumer health products, offering market-leading solutions to its customers. With ISO 13485-accredited facilities, ISO 14644 cleanroom production and over 80 years of experience, Rosti is your trusted partner in navigating regulatory challenges and transforming your product from concept to reality. At Rosti, technological capabilities and manufacturing expertise goes hand in hand with management capability and years of experience, ensuring that Rosti meets and exceeds the industry’s rigorous standards. The company’s certifications guarantee precision, quality and
performance across all projects, from individual components to full device manufacturing. With strategically located manufacturing facilities worldwide, Rosti leverages deep global and local knowledge, fully compliant with both MDR and FDA requirements. The company’s multi-million-euro investment in state-of-the-art innovation labs across all regions supports agile development, accelerating the journey from idea to market more efficiently and cost- effectively than traditional methods. Positioned at the centre of the supply chain, Rosti is committed to making a positive environmental impact. Rosti influences product design, material selection and waste management, embedding
Benefits of X-Pure gelatin in flowable haemostat applications
times its weight in blood and can expand by 200%.
■ Stabilises thrombin: Gelatin, unlike other biomaterials, stabilises thrombin and is therefore an ideal candidate to deliver thrombin – an enzyme that converts fibrinogen to fibrin, forming a stable clot – to the bleeding site.
■ Rapid and effective haemostasis: Fast-acting haemostasis keeps the surgical field clear and helps to reduce the need for blood transfusions and minimise overall surgical time, leading to improved outcomes.
■ Biocompatible and absorbable: Gelatin
integrates safely into the body, reducing the need for post- surgical removal and lowering the risk of complications.
Illustration of a flowable haemostatic matrix made with Rousselot X-Pure gelatin, designed for rapid and effective bleeding control in complex surgical settings.
Flowable haemostatic matrix solutions are effective and versatile agents for controlling bleeding in various surgical settings. Their ability to conform to complex wound surfaces and deliver rapid, localised haemostasis, means they can be used in surgeries involving delicate tissues or hard-to-reach sites. Flowable haemostats combine the mechanical properties of a gelatin or other absorbable matrix with the biochemical clotting ability of thrombin. Why choose gelatin for flowable haemostats? ■ Precision application: Gelatin based microparticle gel can adapt to different geometries, including irregular or confined surgical sites.
■ High absorption capacity: Gelatin can absorb up to 40
Medical Device Developments /
www.nsmedicaldevices.com
Food grade gelatin contains impurities which are unacceptable for use in medical devices. To help medical device manufacturers in marketing their gelatin based medical device concepts, Rousselot has developed the X-Pure gelatin range. X-Pure gelatin is an ultra-purified version of gelatin that provides regulatory compliance for medical devices. Interested in premium-grade gelatin for your haemostatic devices? Contact Rousselot Biomedical’s team of experts:
biomedical@rousselot.com. We support efficient product development and lab-to-clinic translations and offer dedicated technical assistance to enhance your device’s performance. For more information, please visit our website.
Rousselot
www.x-pure.com
Feedthroughs,
casings and windows SCT Ceramics’ brazed, ceramic feedthroughs and casings are the ideal solution for active implantable medical devices, such
SCT Ceramics’ ceramic
feedthroughs and casings for medical applications.
as pacemakers, cochlear implants and neurostimulation devices. Biocompatible ceramic options include: ■ ALUCER alumina ■ Zirconia ■ Ruby
For clients requiring hundreds of channels, SCT Ceramics provides solutions for ultra- miniaturised and high-density feedthroughs using CerMet technology. All products are inspected and tested for the most important criteria such as: ■ Leak test for hermeticity ■ Electric tests ■ Thermal shock ■ Dimensional inspection
SCT Ceramics works hand-in-hand with clients to co-develop and manufacture each custom component. Engineering and development teams provide: ■ Proof of concept ■ Prototyping ■ Costing ■ Qualification and validation ■ Industrialisation and scale-up ■ High-volume manufacturing
SCT Ceramics facilities are dedicated to biocompatible and medical applications. SCT Ceramics is certified ISO 13485 and have ISO 8 clean room, as well as an accredited research lab. The company’s quality teams ensure that our components allow clients to meet strict FDA, CE and NMPA (formerly CFDA) regulations and respond to ISO 10993 biocompatibility standards. IQ, OQ and PQ phases are baked into SCT Ceramics’ overall process validation and leading
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