Atlas Biomed joins the ranks of international medical device companies with ISO 13485 accreditation.
We’ve made it our mission to build a healthier future for humanity where preventable diseases can be stopped before they start. To do so, our team of medical experts, bioinformaticians, and doctors have harnessed advanced technologies and made them affordable for the public.
Our dedication to providing the highest quality of services means that we seek out means to measure and improve what we do every day.
That is why ISO 13485:2016 is so important to Atlas Biomed. This international standard assesses the quality systems in place for medical devices. It is a rigorous independent accreditation that is only awarded to companies that consistently meet the requirements of customers and regulators.
Our core values
Behind the labcoats of our scientists, there are other experts who are rarely celebrated, yet their work is no less important. These colleagues have tirelessly worked to document our procedures, track our records and, audit our work to ensure that every decision we make is the best one for our customers.
“Transforming people’s health is not simply a question of having a great idea – like developing integrated DNA and microbiome tests for the public. It requires incredible drive and effort in some less exciting areas, like compliance and quality management,” explains Sergey Musienko, co-founder and CEO of Atlas Biomed.
No stone was left unturned during our concerted effort to achieve ISO 13485 status because we take our role seriously when it comes to protecting our customers in every manner possible. Here are some of the areas that our quality team assess on a regular basis:
- design and development
- production and traceability
- storage and distribution
- feedback and support
- management and reporting
- processes and procedures
- risk management
When quizzed about the next steps for Atlas, Sergey highlights the importance of consistency, “This is a continuous process of review and evaluation to determine what we can do better every day, every month and every year. I’m extremely proud of the work put into the quality management system by every department at Atlas.”
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