Spanish medical devices manufacturer specialized in innovative ophthalmology solutions for healthcare professionals offers its facilities under subcontracting and outsourcing agreements to carry out process upscale, industrialization and product testing.

The Basque country based R&D intensive company that was founded 28 years ago, designs, manufactures and commercializes medical devices for treatment and surgery in the field of ophthalmology. More specifically, they’re specialized in intraocular lenses and other advanced products for intraocular surgery. This SME is also experienced in fabricating anesthesia and respiratory tract devices (instruments and tools) for cranium-maxillofacial reconstruction and airway tract surgery in humans and animals. This Basque SME wants to open new business opportunities through outsourcing and subcontracting in international markets by offering its know-how and infrastructure capabilities. Their premises are equipped with all the required machinery and technology to produce and package ophthalmologic implants and other products involved in eye surgery (also veterinary applications). An outsourcing and/or subcontracting approach will allow potential partners to test high-tech production processes and products as well as to plan upscale and industrialization measures. The technology and facilities offered to potential manufacturing and services agreements include the following: • Design of new ophthalmological implants, manufacture, sterilization and commercialization of intraocular lenses and other medical devices as well as wide variety of products and instruments used in surgery. • Availability of clean rooms ISO5 / ISO6 / ISO7 for product assembling and packing for third parties. • Possibility of sterilization using Ethylene Oxide or steam. • Laser marking of surgical instruments or others for product customization. • Availability of classrooms for surgical training courses and Wet Labs for the diffusion of the last clinical procedures and researches in ophthalmology. • Regulatory advisor support in the preparation of CE technical documentation in compliance with ISO 13485 and the European Medical Device Regulation MDR 2017/745. The company could also support with advisory tasks in the process of applying for clinical trials and their submission to Spanish Health authorities. All materials and processes used by this company are biocompatible with human and animal tissues. The sterilization of their implants manufacturing machines is ensured by the implementation of highest demanding standards. This company has a long track of successful R& D and innovation projects. Thus, they would also be interested in a subcontracting cooperation scheme in the framework of research projects put forward by industry, research centres or universities.