Develop and produce the first domestic biodegradable and bio-absorbable polymer materials for surgical sutures

Biodegradable and absorbable polymer materials

In 1986, through research collaboration with BMG, Gunze obtained approval from Ministry of Health and Welfare for producing the first domestically produced bio-absorbable surgical sutures. This triggered production by BMG of medical-use polymer (PGA) materials for surgical sutures, for the first time domestically.

Thereafter, BMG had stepped forward to PGA production in larger quantities and also had been actively engaged in development and production of various types of biodegradable polymer materials:

In 1996, production of Poly-L-lactide (PLLA) materials for biodegradable and absorbable bone fixtures was commenced;

In 1997, production of Poly(L-lactide-co-ε-caprolactone) (LCL) materials for biodegradable and absorbable monofilament surgical sutures was commenced.

›› Detail of Polymer Products

Development of medical-use polymer materials
and devices for new applications

Newly developed products

Making use of own advanced professional techniques in medical-use polymers, BMG not only supplies various types of biomaterials but also is engaged in developing a broad range of medical devices including dental one.

›› Detail of Newly Products

Engagement in advanced medical technologies

Research & Development

BMG has been engaged in development of advanced medical technologies through long-term close research collaboration with Institute for Frontier Medical Sciences, Kyoto University, contributing to our keeping higher advanced techniques and the lead in biopolymer suppliers. BMG will keep carrying on pioneering works to contribute to progress of the world’s medical technologies.

›› Detail of Research & Development

Pursuing for quality improvement

BMG Inc. has been aiming at higher-level quality management in accordance with global standards. Our quality assurance department has been engaged in improving and enhancing the quality management/assurance system. In March 2007, we successfully obtained ISO 13485 typically given to medical device companies satisfying global standard requirements.

Applied Standard:

ISO 13485:2003

Medical Devices — Quality Management Systems —

Requirements for regulatory purposes

Certificate No.:

Q1N 07 03 60103 002

Date:

2007-03-05

Holder of Certificate:

BMG Incorporated

45 Minamimatsunoki-cho, Higashikujo,

Minami-ku, Kyoto 601-8023, JAPAN

Scope of Certificate:

Design and Development, Production and Distribution of Thermoplastic Denture Resin and Raw Materials for Medical Devices (Bio-absorbable Suture, Bone Fixation Material, Membrane Sheet for Periodontal Disease and Adhesive Composition of Surgery)

Certified by:

TÜV SÜD Product Service GmbH

Certificate Image: