Aniling Renews ISO 13485:2016 Certification

Aniling, a biotechnology company specialized in diagnostics using a unique and proprietary technology analyzing both genomic and epigenomic biomarkers, is proud to announce the successful renewal of its ISO 13485:2016 certification, a globally recognised standard for quality management systems within the medical device industry. This accomplishment demonstrates Aniling’s dedication and commitment to upholding the highest compliance quality standards in this field, providing top-notch quality and reliability in its products. 

To keep its ISO13485:2016 certification, a reassessment audit is conducted by BSI every 3 years at Aniling, besides the surveillance audits scheduled on an annual basis. The continuous maintenance of this certification demonstrates the ability of Aniling’s quality management system to manufacture medical devices which consistently meet the applicable regulatory requirements. 

Last month, Aniling passed with great success the reassessment audit with the scope “design, manufacturing and testing service of IVD test for CLL/leukemia/cancer diagnosis, prognosis and treatment decision making” defined under the certificate number MD 732651 that can be authenticated using the BSI Directory of Certified Clients here.

“We believe that quality is key in getting cutting-edge innovations in medicine to the patient. The renewal of our certification is just an example of our strong commitment”, says Dr Llorenç Coll, co-founder and CEO of Aniling.