The Hague, Netherlands, July 6, 2022: Amber Implants, an innovative medical technology company developing next generation spinal implants for spinal injuries, today announces that it has received ISO 13485:2016 & EN ISO 13485:2016 certification for design, development and manufacturing of orthopaedic spinal implants and surgical instruments.
ISO 13485:2016 is an internationally recognized quality standard specific to the medical device industry that ensures the quality of medical device design, development and production. Companies that achieve ISO 13485 certification must consistently meet customer needs, medical device regulations, and strict requirements of the International Organization of Standardization (ISO).
“We’re extremely proud receive this world-class certification for our quality management system.” remarked Dr. Banafsheh Sajadi, Founder & CEO of Amber Implants. “Our quality management team holds our products to the highest standard as is expected by our future clinical customers and users.”
In achieving compliance with the standard requirements, Amber Implants chose a reliable partner – BSI.– a global leader in auditing, inspection and certification, delivering high quality services to help companies to meet the growing challenges of quality, safety, environmental protection and social responsibility. BSI reviewed Amber Implant’s management system and provided certification to the standard as an independent third-party specialist which provides the clients with independent assurance on Amber Implants’ commitment to quality.
For more information about setting up a quality system according to ISO 13485 see our whitepaper.
About Amber Implants
Amber Implants is a medical technology start-up located in the Netherlands and United States. Founded in 2018, the Company has developed VCFix® Spinal System as the next generation of treatments for vertebral compression fractures, and is focused on improving patient outcomes through implants that provide more natural healing and stability. Amber Implants aims to create more unique solutions for spinal and other orthopaedic disorders in future.
About VCFix®
The VCFix® Spinal System is the first solution able to treat a broad range of vertebral compression fractures (VCFs) without need for bone cement. With its unique design, the VCFix® implant can stimulate bone ingrowth, providing a more natural healing process. It is optimized for mechanical strength, maximum fracture reduction and anatomical restoration. The VCFix® implant provides pedicle anchorage for better stability, better distribution of loads in the middle and posterior columns of the spine, as well the possibility for posterior fixation for more unstable fractures. The VCFix® Spinal System also includes a user-friendly single-use sterile surgical kit for perfect traceability and reduced risks of infection. VCFix® will be the new generation of treatment, providing an easier, more efficient and safer solution for patients with vertebral fractures.
For more information and to receive the certificate, please contact us at info@amberimplants.com