Good news丨Basecare has successfully passed the ISO13485 quality management system certification
The ISO-13485 standard is the GMP standard of the international medical device industry, which has been highly valued and widely recognized by the global medical device industry, regulatory authorities and society. This international standard level is based on risk management requirements, and has become the highest standard in the international medical device industry through the control of the entire life cycle of medical device products, the management of suppliers or other external parties, and the reporting of post-marketing regulatory agencies.
This certification means that the R&D, production and quality management level of Basecare has reached the international standards and regulatory requirements, which is highly compatible with medical device regulations, and are fully consistent with the expectations of the medical device industry and the public, and laid a solid foundation for the company’s globalization.
ISO-13485:2016 quality management system certification
The scope of this certification covers all related departments and active processes in the company’s quality management system. All departments of the company actively cooperate with the review process of the expert group with a rigorous attitude. Relevant departments also actively responded to the questions raised by the review experts. Effective solutions were given, and the discussion results of the review meeting also clarified the direction for the continuous improvement of the company’s quality management system, laying a solid foundation for the subsequent quality management work.
The ISO-13485 standard levels are general standard levels for the international medical device industry. It’s known as “Medical Device quality management system for regulatory requirements”. It is a special requirement for the quality management system of medical device manufacturer. International medical device has always regarded ISO-13485 as an important basis for quality management system certification, which is mainly used to assess the design and development, production, installation and service of medical device, as well as the design, development (Preimplantation chromosomal aneuploidies detection kit, semiconductor sequencing) and provision of related services. It can also be used internally and externally (including certification bodies) to assess the organization’s ability to meet the customer and regulatory requirements. Being awarded by ISO-13485 certification is the recognition and affirmation of Basecare’s quality management system. Quality is the foundation of the company’s honest management. Only by guaranteeing quality can the company be recognized and trusted by more customers. Basecare will continue to uphold its original intention and continually strengthen the management system guarantees for the design and production of high-quality medical device products.
Suzhou Basecare Medical Device Co., Ltd is a high-tech leader invested by Sun Yat-Sen university Daan Gene Co., Ltd. (stock code 002030), committed to the research and development and clinical application of high-throughput sequencing technology in the field of reproductive health. In 2016, the PGT-A kit was granted special approval for innovative medical devices by the CFDA Medical Device Technology Evaluation Centre. In 2017, Basecare participated in the formulation of the first PGT technical standards, Quality Control Technical Evaluation Guide of Preimplantation Chromosomal Aneuploidies Detection Kit, which laid a solid foundation for the clinical application of third-generation IVF technology.
In 2019, the international renowned video experiment journal JOVE published online the standard experimental procedure for Basecare preimplantation chromosomal aneuploidy test as known as “PGT-A”. The experimental procedure published by JOVE magazine has been recognized and followed by more than 60 national academic institutions and scientific research institutions around the world. This time, the PGT testing standard procedure completed by Basecare is shown as an international standard in JOVE magazine. It is of great significance of China’s PGT testing process standards. Up to now, Basecare has established localized joint laboratories with 31 reproductive medical institutioins across the country, has developed business cooperation with more than 200 domestic reproductive centers, operated 4 independent medical testing laboratories across the country, and has established 1 international inspection laboratory in Hong Kong. Basecare will keep its mission and vision in mind, help every family have a healthy baby, and make Basecare an international brand in the field of reproductive health!