As every year, Obelis Group is thrilled to actively participate in Arab Health, providing a unique opportunity for manufacturers worldwide to connect personally with us.
Meet us at our booth (Z2.A36) for a free regulatory compliance session to address your specific concerns and inquiries. Our experts will be available to provide valuable insights and guidance, ensuring that you leave with a clearer understanding of how Obelis can contribute to your regulatory journey. You can book your free meeting here.
We are proud of our successful collaborations and want to share the story of our esteemed client, a renowned medical devices manufacturer, Samsara Vision, specialised in helping patients with severe retinal disorders.
How our collaboration with Samsara Vision started
In 2019, Samsara Vision discovered Obelis. Through meticulous research, this medical device manufacturer leader recognised Obelis as the strategic partner capable of guiding them through the intricate landscape of EU compliance.
The Challenge Samsara Vision faced the daunting task of introducing their implantable ophthalmic device for age-related macular degeneration (AMD) to the European market. The company had to navigate a complex web of regulations, certifications, and local authorities to ensure compliance with EU standards. Despite these obstacles, Samsara Vision was able to successfully bring their innovative device to the market with the help of their partnership with Obelis.
The compliance journey
Samsara Vision appointed Obelis as their European Authorised Representative and MDR consultant. The collaboration involved national registrations in Italy, Spain, France, Portugal, Greece, Belgium, and the UK. Obelis provided critical support and advice, ensuring swift regulatory approval and compliance. Obelis acted as an intermediary between Samsara Vision and EU regulatory authorities, simplifying communication and expediting the approval process. With Obelis guiding them, Samsara Vision was able to navigate the complex regulatory landscape smoothly, avoiding potential obstacles and ensuring compliance with the highest standards.
Today, Samsara Vision stands as a testament to enduring success in the highly competitive EU medical devices market. Free from the burdens of dealing with local authorities and regulatory challenges, Samsara Vision can focus on innovation and business growth. Obelis remains committed to providing continuous support and expertiseur Implantable Miniature Telescope is essentially a miniaturized telescope designed for individuals with age-related macular degeneration (AMD), an irreversible loss of straight-ahead vision that is impossible to correct by glass, drugs, or surgery.
Your authorised representative for any compliance challenge
If you find yourself facing challenges like those encountered by Samsara Vision, remember that Obelis is here to help. Our experienced team is dedicated to supporting you in achieving compliance excellence and fostering your success in the global market. Visit us at booth Z2.A36 and let’s embark on this regulatory journey together.
Meet our Arab Health 2024 team:
Shikha Malhotra: Global Sales Manager – Obelis Group
Cecilia Battista: Junior Manager Customer Relations
Fabrizio Gallo: Expert consultant – VIP consultant
Francesca Santacatterina: Expert Consultant – Regulatory Intelligence & Innovation
Silvia Zarzuela Martin: Consultant – Business Development department
Can not make it? Schedule a free call with one of our experts
Giada Rosignoli – Marketing Department
25.01.2023