3D-printed resorbable implant technology achieves ISO 13485 certification

Medtech startup BellaSeno (Leipzig, Germany) has obtained ISO 13485 certification for the design and additive manufacturing (aka 3D printing) of resorbable implants. As such, it claims to be among only a handful of companies worldwide to offer integrated contract additive manufacturing of implants under the ISO quality management standard specific to medical devices. In the same announcement, BellaSeno said that it had raised a further €1 million from its existing investors, bringing total funding to €4.2 million for the startup founded in 2015. The certification and funding will enable the company to initiate clinical trials of its first product Senella, a biocompatible and fully resorbable breast scaffold. Those benchmarks are also helpful in closing "contract manufacturing deals with companies seeking to develop and market their own resorbable implants for a wide range of medical applications,” added CEO Simon Champ. “We are offering the entire process under ISO 13485 certification to other medtech companies worldwide, from concept and in-house design to manufacturing of prototypes, clinical trials and series production.” The company’s signature Senella device is a patented, porous, resorbable scaffold that, BellaSeno believes, represents a step change in breast reconstruction and augmentation technology. It has the potential to disrupt the current breast surgery marke...
Source: MDDI - Category: Medical Devices Tags: Plastics Today Source Type: news