FSOFT expands scope of ISO 13485:2016 certification, demonstrating exceptional competence in the medical field

After a six-month project involving three rounds of evaluations, FSOFT has officially obtained the ISO 13485:2016 certification for the Japanese market.

This certification is an international standard for quality management systems specifically for organizations involved in the medical device industry. Achieving ISO 13485:2016 certification will enhance FSOFT’s standing in medical device manufacturing and unlock numerous new business opportunities. Previously, FSOFT Vietnam attained this certification at the end of 2022.

This achievement is a result of the collaborative efforts of multiple units, including GHC.GHS, GHC.IMS, GHC.COE, FJP.GHC, FQC HCM, and SEPG from the delivery division, as well as GRC, FSA, PRC, IT, FID, SSC, and FST from the BA division. According to the project team, the certification journey spanned several phases, starting from late 2022 to mid-May 2024, covering both offshore and onshore operations. In late 2023, FSOFT initiated the project to expand the certification to its operations in Japan, with GHC taking the lead. After numerous evaluations, on May 16 and 17, software production projects for medical devices such as ultrasound machines, endoscopes, and X-ray machines, managed by GHC with its clients, were thoroughly inspected and found to have zero non-conformities.

Obtaining the ISO 13485:2016 certification has significantly boosted FSOFT’s image in the medical device manufacturing sector, standardizing the quality management processes for medical device development projects and improving the quality of related medical projects. This milestone underscores the company’s commitment to ensuring quality and safety in medical device production, enhancing trust and credibility with clients and partners globally, and opening up potential business opportunities with major medical device manufacturers in Japan, the US, and other markets.

ISO 13485:2016 emphasizes risk management, regulatory compliance, product testing, and traceability throughout the product development process. Given the high-risk nature of the field, directly impacting human lives, the certification assessment process is notably stringent. The certification is valid for three years and is subject to periodic reevaluation.