AJJ is pleased to announce that on 2 August 2021, we have successfully obtained ISO 13485:2016 & EN ISO 13485:2016 (“ISO 13485:2016") certification, which certifies that AJJ has complied with the applicable international standards for the design, development, manufacture, distribution, installation and servicing of High Intensity Focused Ultrasound (“HIFU”) tumour therapeutic systems.
What is ISO 13485:2016?
ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organisations in the supply chain. Obtaining ISO 13485:2016 certification is becoming increasingly relevant and essential for doing business in today’s medical devices industry, as it gives clients and/or consumers confidence in the certified company’s medical devices and services.
An essential milestone.
ISO 13485:2016 is a set of international standards which ensures that all medical devices manufactured and distributed by certificate holders are of international recognised standards in terms of safety and quality.
ISO 13485:2016 represents an essential milestone for AJJ Healthcare Management. It demonstrates our quality control and stringent processes, with a focus on constant research and development of better technology in the future. In addition to the previously acquired SS 620:2016 Good Distribution Practice for Medical Devices (“GDPMDS”) certificate on 1 October 2020, this means that AJJ is now a globally and locally certified manufacturer and distributor for safe, quality and high performing medical devices, which may propel us to achieve further business growth and seize market opportunities in the years to come. AJJ intends to build on the aforesaid first steps in expanding its Healthcare Business Division in Singapore, followed by Southeast Asia and globally.
What's next for us?
AJJ is in the process of expanding the scope of its ISO 13485:2016 certification for the import, manufacture, storage, distribution of X-Ray Machine, Electrocardiograph, Portable Isolation Chambers, Ventilators, Disposable Anesthesia Breathing System and Accessories, Continuous Positive Airway Pressure Masks, the servicing of X-Ray Machine, Electrocardiograph, Portable Isolation Chambers and Ventilators and the installation of X-Ray Machine. AJJ is also planning to procure its growing range of sterile products to be certified in the near future.