Particle3D initiates implementation of the Quality Management System for the P3D Bone implant
December 11th, 2020, Particle3D’s executive management signed the first fundamental procedures of the Quality Management System which will lay the foundation for the market approval and registration of the P3D Bone implant in the USA.
The Company has thereby commenced the implementation of a medical device Quality Management System with a view to achieve ISO 13485 certification – the international standard for quality management systems in the medical device industry. This presents a big step towards the establishment of a production in accordance with regulatory and international standards in order to produce P3D Bone implants for human use.
With QA Manager, Helene Meins, at the helm of the initiation and maintenance of the Quality Management System, the quality assurance plan has been introduced. The initially signed documents include the Company’s quality manual that will secure successful implementation prior to US market launch and registration. With the execution of the presented quality manual, Particle3D will ensure that it meets the requirements of customers and the organization itself to ensure compliance with regulations and good operating practice.
Particle3D has established good proof of concept in large animal models, most recently with the successful completion of a six month pig trial. The expectation is to reach human application with the first version of the P3D Bone implant upon FDA approval in the first half of 2022. The first available P3D Bone implant is a natural, 3D printed, and resorbable bone graft substitute with organic bone porosity provided in standardized shapes.
Particle3D is a Danish MedTech company founded on proprietary technology to 3D print patient specific, natural and resorbable bone implants. This enables fast ingrowth on bone tissue, remodeling into real living bone, and results in fewer complications. The technology can also be used for 3D printed R&D products, implants with additives, such as antibiotics or other drugs, and even in industries outside healthcare. Website Particle3D – We Print Bone.