It should come as no surprise, that success in medical devices means overcoming compliance challenges.
The business case for quality compliance is undeniable – quality affects every stakeholder in the medical value chain.
Quality is a central concern from product design through manufacturing and marketing.
Medical Device Manufacturing Certificate
IDL is leading the pack with an ISO 13485:2016 – Full Quality Assurance System certification for medical devices. This combination of the highest level of Quality Management System certification and top-tier Notified Body is among the most difficult and globally recognized certifications to obtain and maintain.
We try harder
We mantain our quality management system through documented procedures, qualification of personnel, validation of processes and an emphasis on customer satisfaction and feedback. IDL continues its quality management system preservation with monthly quality and data analysis meetings, bi-annual internal audits, and an annual external audit from an ISO certification body.