ORIOS LifeSciences

ORIOS LifeSciences is a French MedTech company providing integrated services across the entire medical device lifecycle, from early-stage development to industrialization, testing, manufacturing and dedicated production equipment.

We support medical device manufacturers, start-ups and technology companies with a combination of technical expertise, regulatory understanding, industrial know-how and hands-on manufacturing experience. Our objective is to help our customers accelerate development, reduce technical and industrial risks, secure manufacturing processes and bring robust, compliant and scalable medical devices to market.

ORIOS operates through five complementary areas of expertise:

Consulting
We provide senior expertise in R&D, industrialization, operational excellence, Quality Assurance and Regulatory Affairs. Our teams support product and process development, remediation activities, process validation, risk management, CAPA, supplier qualification, manufacturing troubleshooting and quality system improvement.

Our Regulatory Affairs support can also cover broader strategic topics such as regulatory strategy, product registration, market access, licensing activities, interactions with competent authorities and notified bodies, technical documentation preparation and remediation, MDR/FDA readiness, and outsourced PRRC activities.

We can therefore support companies not only in maintaining compliance, but also in defining the most appropriate regulatory pathway to place or maintain their products on the market.

Contract Development Organization (CDO)
ORIOS supports the complete development of medical devices, from initial specifications and feasibility through prototyping, Verification & Validation, industrialization and production transfer. Quality and Regulatory Affairs are integrated throughout the development process. Our teams combine product engineering, materials expertise, process development, risk management and manufacturing knowledge to ensure that devices are not only technically successful, but also robust, manufacturable and scalable.

Testing
Our testing capabilities support R&D, product characterization, Verification & Validation, process qualification and manufacturing activities. Services include dimensional and mechanical testing, tensile testing, burst pressure, fatigue, balloon compliance, leak testing, particulate testing and simulated-use testing. We also develop customized test methods and protocols for specific devices and applications. Our objective is to provide reliable data together with technically meaningful interpretation.

Contract Manufacturing Organization (CMO)
ORIOS provides flexible manufacturing solutions for prototypes, pilot batches, validation lots and commercial production. Our capabilities include technical tubing extrusion, molding and overmolding, balloon forming, welding and reflow, braiding and coiling, crimping, hydrophilic coating and sterile barrier packaging. Our manufacturing environment includes ISO 7 cleanroom capabilities and is particularly adapted to complex catheter-based and minimally invasive medical devices.

Industrial Equipment
We design and develop dedicated industrial equipment for medical device manufacturing, with a strong focus on catheter production and polymer processing. Our capabilities include thermal welding equipment, lamination and reflow systems, angioplasty balloon forming machines, tube stretching equipment, hydrophilic coating systems and customized production tools. Equipment development can include process characterization, automation, parameter monitoring, qualification support, training and transfer to the customer’s manufacturing site.

ORIOS has particular expertise in vascular, interventional and catheter-based medical devices, including balloon catheters, delivery systems, microcatheters, technical tubing and complex polymer assemblies. Our experience covers key manufacturing technologies such as extrusion, thermoforming, balloon forming, bonding, welding, pleating, folding, crimping and assembly.

A key strength of ORIOS is the integration of development, regulatory support, testing, manufacturing and industrial equipment within the same organization. This creates strong continuity from concept to market and enables us to identify manufacturing and regulatory constraints early, optimize processes during development and accelerate transfer to industrial production.

We can support customers on a specific technical or regulatory challenge, provide targeted expert resources, manage complete development programs or act as a long-term industrial partner.

Our ambition is to build strong, transparent and long-term collaborations with medical device companies looking for a responsive, experienced and technically capable partner to support innovation from concept to market and manufacturing.