ISO 13485
ISO 13485 is an international standard for quality management systems in the field of medical devices. It is intended for manufacturers, suppliers, and organizations in the medical device supply chain, with the goal of ensuring the safety and quality of products that impact human health and life.
Why ISO 13485?
ISO 13485 sets specific requirements for product quality and compliance with regulatory frameworks worldwide. The standard covers the entire product lifecycle – from design, development, and manufacturing, through storage and distribution, to installation and servicing.
Implementing ISO 13485 ensures:
- compliance with legal requirements,
- risk control related to medical devices,
- patient, user, and regulatory body confidence,
- easier access to international markets.
What Do We Offer?
Our team supports you in implementing ISO 13485 through:
- analysis of existing processes and identification of improvement areas,
- development and documentation of quality procedures and plans,
- employee training on standard and regulatory requirements,
- conducting internal audits and preparing for certification,
- continuous support in maintaining and improving the system.
ISO 13485 guarantees that your medical devices are safe, reliable, and compliant with the highest international requirements.