Constance, the 18th September 2017. stimOS GmbH successfully achieved ISO 13485:2016 certification (Notified Body: QS-NB1254) for its integrated high quality management system across all stimOS corporate functions from design and development to manufacturing and supply.
To obtain this internationally recognized and approved quality certification, an organization must establish and maintain a high-level quality management system that is compliant with all regulatory and legal requirements, and that ensures the safety and performance of the company´s processes, products and services.
stimOS GmbH has completed its certification process in September 2017: The company, based in Constance, has effectively implemented a quality management system which demonstrates its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
stimOS ISO 13485:2016 certification includes design, development and production of stimOS Mimicking Bone Technologies
EN ISO 13485 certification demonstrates stimOS´ commitment to quality and attention to detail in the development and provision of stimOS patented Mimicking Bone Technology [MBT].
EN ISO 13485:2016, the international standard for medical device quality management systems, differs from the ISO 13485:2012 version of the standard in its increased emphasis on risk management. It also harmonizes more closely the quality system regulations found in FDA 21 CFR Part 820, the law for medical device companies manufacturing or selling products for the US market.
stimOS QMS: Compliant with current Medical Device Directive, prepared for Medical Device Regulation and FDA 21 CFR 820 Requirements
“The certification in its latest 2016-version is a milestone achievement for stimOS GmbH. It demonstrates to the international community that we are passionate about providing exceptional quality in all aspects of our business, always being up-to-date, in order to improve implant material safety and performance,” says Dietmar Schaffarczyk, Managing Director of stimOS GmbH.
stimOS products for implant surface functionalization under the label MBT are available in three different categories: MBTg, MBTv and MBTti. All stimOS surface functionalization technologies show superior results concerning the growth of bone cells. A comparative study made by the University of Constance demonstrates excellent results for all MBT surface treatments compared to commonly available implant materials.
Mimicking Bone Technologies: Inspired by Nature, Developed by stimOS, Certified ISO 13485
The study results can be requested via email: firstname.lastname@example.org.
|stimOS GmbH achieves ISO 13485:2016 certification|
stimOS GmbH was founded in May 2015 by Prof. Dr. Helmut Cölfen, Prof. Dr. Günter Schatz, Prof. Dr. Johannes Boneberg and Dr. Dietmar Schaffarczyk. stimOS develops innovative technologies and procedures that refine, functionalize and activate implant materials. As a supplier and service provider, stimOS makes these technologies available to implant manufacturers. Furthermore, the company offers services in the field of product development and certification, and develops with the product line spineFuseMBT implants for spinal fusion surgery.
About MBT - Mimicking Bone Technology
With MBT, stimOS offers the surgeon and the patient a completely new solution: MBT operates as a „stealth technology“ for the implant, transforming a neutral implant surface into a bone- identic implant body interface. stimOS opens new, innovative paths by modifying the surface structure of implant materials biochemically by means of a covalently bound activation layer, rather than relying on coating technologies. MBT gives even inert materials biological properties close to nature and similar to those found naturally in the human body.
QS Zürich AG is in the service of customers since 1996 and accredited since 1998 as certification body for management systems, as Notified Body for Medical Device and ATEX of the European Union (NB 1254). QS is represented on the international market worldwide, with more than 32 languages and over 13′000 issued certificates.
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