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Big step towards market approval and registration: Ossiform initiates QMS implementation

Ossiform initiates implementation of the Quality Management System for the P3D Bone implant

December 11th, 2020, Ossiform’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, Ossiform will ensure that it meets the requirements of customers and the organization itself to ensure compliance with regulations and good operating practice.


Ossiform 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 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.

About Ossiform
Ossiform 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 Ossiform – We Print Bone.

Our mission is your benefits

Our mission is to provide 3D printed natural bone implants to reduce complications, improve functional & aesthetic outcomes, and obtain faster recovery.

Natural bone porosity, optimized for bone regeneration 

The unique structure of the P3D Bone is designed to facilitate the natural forming of new bone.

Remodels into real living bone

The natural material and structure ensure effective remodeling of the implant into new vascularized bone.

Patient specific - designed with the patient's uniqueness in mind

The P3D Bone is 3D printed to enable a full restoration of the functionality and appearance of bones.

Resorbable material with structural support

P3D Bone eliminates the need to harvest bone as well as the need for permanent and ill-fitting implants.

P3D Bone Void Filler is expected to launch in 2023

Our first 3D printed, resorbable P3D Bone with modifiable dimensions and a lifelike bone architecture

P3D Bone Patient Specific Implant is expected to launch in 2024

Our patient specific and resorbable P3D Bone based on the patient’s own CT/MRI scan data

We Print Bone​™

Contact us here

Contact us for questions, general inquiries, or to request a quote.
We strive to provide you with highest quality service and expertise in medical 3D printing.

 
 
 
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Do you have questions?

Give us a call or write to us by email: info@ossiform.com

We will get back to you as soon as possible.​

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Ossiform ApS - We Print Bone™

​Oslogade 1, 5000 Odense C​, Denmark

CVR. 38838512

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