SINGAPORE – FEBRUARY 26, 2019
Meeting Quality Management System (QMS) requirements is clearly a global need, across all borders. Overcoming language barriers, Stendard is excited to announce a further collaboration with MEDITIP Co. Ltd., in Seoul, Republic of Korea, to bring Korean medical device companies the world’s first bilingual compliance platform: Stendard Solution™.
The Republic of Korea has long been known for its established regulations and proper work practices. Positively correlated is the large number of healthcare and medical device companies - regulated by the existing local Korean Good Manufacturing Practice (KGMP). Increasingly, more Korean companies are serving international clients. This makes fulfilling the international ISO 13485 requirements important as well.
Yet, the inertia of getting the ISO 13485 certification is not completely removed as cost remains high, and much time is required for the preparation of relevant documents and implementation of procedures.
To tackle this issue, the use of, and benefits of the Stendard Solution™ was recognised by Dr. Yoo JeoungHee and his MEDITIP team early on. With accurately customised documents produced and easily implemented on cloud, the Stendard Solution™ was clearly the answer to overcome a hurdle of getting certified.
“Still, the limiting factor of adoption was having documents produced in English. With businesses in Korea largely run by locals, Korean is the primary language of communication, and QMS documentation is naturally preferred to be in Korean. As advocates of standards adoption, Stendard has developed the world’s first English-Korean bilingual option to support our clients”, said Mr Jason Lim, CEO and Co-founder of Stendard.
“Not only do the fully automated customisation of documents through Stendard Solution™ meet both ISO 13485:2016 and KGMP requirements, they are also presented in both Korean and English languages. This is one big step to help our local medical device companies go global”, said Dr Yoo JeoungHee, CEO of MEDITIP Co., Ltd.
Monthly workshops are now being conducted by MEDITIP to aid companies looking to be ISO 13485:2016 certified and/or KGMP certified. The training covers theoretical content which provides participants with an understanding of the standard’s requirements, as well as a practical element, where they prepare their set of documents through Stendard Solution™.
Through this partnership of Stendard and MEDITIP, medical device companies in the Republic of Korea can look forward to smoothly solving the challenge of staying compliant to local and international regulatory demands.
Stendard’s mission is to create intelligent platforms to help businesses adopt standards, build processes and accelerate global growth. Starting with the MedTech and Food industry, Stendard Solution™ has supported more than 200 companies in regulated countries, such as Korea, Germany, Australia, India and Singapore, on their journey to fulfill ISO standards. Since launch, our clients have been successfully audited by international Certification Bodies with more than 90% cost and time savings. Our vision is to be the digital infrastructure for the regulatory compliance and standards ecosystem.
Media enquiries can be directed to:
Your Butler | Stendard
MEDITIP Co., Ltd. is a professional healthcare consulting company, providing quality consultation services regarding efficient product registration, compliance to regulatory and post-market affairs, clinical trials, global market clearance management, R&D and more. With a strong local presence in the Republic of Korea, clients include large pharmaceutical and medical device companies, as well as leading Korean firms.
Media enquiries can be directed to:
Mr. HeeEog Shin (신희억)