(주)비욘드디엑스 체외진단의료기기 제조 및 품질관리 기준 적합 인정 획득
2024-12-09 15:09:57
다중통합분석 솔루션 개발 기업 비욘드디엑스가 암 스크리닝 시장 진입을 본격화합니다. 경기도 광명시 하안로 60, C동 1506호, 1507호 1508호의 GMP 제조소에 대해 한국산업기술시험원(KTL)와 식품의약품안전처의 심사를 거쳐 체외진단의료기기 제조 및 품질기준(GMP)을 충족함을 인정받았습니다.
지난 8월에 획득한 ISO 13485:2016 국제 표준과 더불어 체외진단의료기기법 시행규칙에 따른 시설과 제조 및 품질관리체계의 국내.외 기준에 적합한 생산 인프라를 확보하게 되었습니다.
비욘드디엑스는 검증된 생산/개발 인프라를 기반으로 ForeCheck LC의 국내.외 허가와 상업화 파트너십을 구축하는 사례를 보여주고, 유럽, 미국 등 글로벌 시장으로 확대해 나가고자 열심히 달리겠습니다.
Privacy Policy
BeyondDx collects the following personal information for services consultation, inquiries, and job applications:
BeyondDx utilizes the collected personal information for the following purposes:
In principle, personal information is disposed of without delay after the purpose of collection or provision has been achieved. During the period of using services, research, and job application procedures, personal information is retained by BeyondDx.
However, it is generally disposed of without delay when the purpose of collecting or providing personal information is achieved. In cases where issues arise during the process of discussing services and job applications, information necessary for compulsory blocking and measures against malicious users will be retained.
BeyondDx disposes of personal information without delay after the purpose of collecting and using it has been achieved.
The procedure and method of disposal are as follows:
BeyondDx generally does not provide users' personal information to external entities. However, exceptions apply in the following cases:
BeyondDx does not entrust personal information to external companies without the user's consent. If necessary, the target and content of the entrusted work will be notified to the user, and the process will proceed after obtaining prior consent.
Users and legal representatives can access, modify, or request deletion of personal information of themselves or children under 14 years of age at any time.
For inquiries related to the viewing of personal information of users or children under 14 years of age, contact the personal information protection manager through writing, telephone, or email for prompt action. If a user requests correction of incorrect personal information, the information will not be used or provided until the correction is completed. If incorrect personal information has already been provided to a third party, the results of the correction will be promptly notified to the third party for correction.
BeyondDx processes terminated or deleted personal information according to the retention and usage period of collected personal information.
BeyondDx operates information storage and retrieval devices such as "cookies" to collect user information.
Cookies are small text files sent by servers used to operate BeyondDx's website to the user's browser. These files are stored on the user's computer hard drive. BeyondDx uses cookies for the following purposes:
BeyondDx protects user personal information and handles complaints related to personal information. Below are the related departments and personal information protection manager designated by BeyondDx:
Personal Information Protection Manager
Name: Yoonjung Lee
Phone Number: 02-6337-0802 (Weekdays: 8:00 AM to 5:00 PM)
Email: yjlee@beyonddx.kr
For reporting or counseling on personal information infringement, contact the following organizations:
Personal Information Infringement Report Center (Phone 118, http://privacy.kisa.or.kr)
Personal Information Dispute Resolution Commission (Phone 1833-6972, http://www.kopico.go.kr)
Cyber Investigation Department of the Prosecutor's Office (Phone 1301, http://spo.go.kr/)
Cyber Safety Bureau of the National Police Agency (Phone 182, http://cyberbureau.police.go.kr/)