Shinwakogyo, operating “Medical Plastic Molding.com”, has been manufacturing various plastic molded products with quality first since its foundation. Because of this, we obtained ISO13485 certification in September, 1980 as a certification of the management system required for precision equipment and medical equipment. Although there are few plastic molding manufacturers that have acquired ISO13485 in Japan, Shinwakogyo has now acquired this certificate as proof of trust and reliability that customers can associate with confidence.

In 2005, a specialized custom-built M / C was deployed to manufacture medical plastic products. Around this time, customers in the pharmaceutical and pharmaceutical industries dominated at Shinwakogyo . Therefore, in 2007, we obtained the medical device manufacturer approval in order to be entrusted with plastic molding from customers who have the medical device manufacturing and sales approval. In this way, plastic molding for the medical industry has become more important than ever before, and now it can handle both hygiene and sterilization processes.
Sterilization is available for DNase-free, RNase-free, and endotoxin-free products, as well as sterilization by irradiation of radiation (gamma rays and electron beams) and EOG sterilization. If you have a medical device manufacturing and sales approval and are looking for the design and production of high quality and complex shaped plastic products, please come to Shinwakogyo which operating “MedicalPlasticMolding.com” to consult us. In addition to quality, we will support to get certification for the product and solve the problems that you are currently having. We also provide consultation on development and design of medical plastic products.

＜　Second-class marketing license for medical devicesx　＞	＜　Registration certificate of medical device manufacturer　＞
＜　ISO13485 registration certificate　＞