Pixacare has obtained ISO 13485 certification — the internationally recognised standard for quality management in the design and manufacture of medical devices. This certification confirms our commitment to delivering wound monitoring and remote follow-up solutions that meet the most rigorous regulatory requirements.
What is ISO 13485 certification?
ISO 13485 is an international standard that defines the requirements for a quality management system (QMS) for organisations involved in the design, development, production, installation and maintenance of medical devices.
It applies across the entire product lifecycle and requires:
- Full traceability of design and manufacturing processes
- Rigorous risk management for medical devices
- Compliance with applicable national and international regulations, including European MDR 2017/745
- Continuous improvement of the quality management system
ISO 13485 is the global reference standard for medical device manufacturers seeking to demonstrate regulatory compliance.
What this certification means for our clients
For healthcare institutions, clinical staff and patients using Pixacare, ISO 13485 certification provides concrete assurance across three areas.
Quality: every stage of the design, development and commercialisation of the Pixacare application is audited and certified as compliant with international requirements.
Reliability: internal processes are documented, controlled and reproducible, ensuring a stable and secure user experience.
Regulatory compliance: Pixacare meets the obligations imposed on Class I and Class II medical device manufacturers operating in Europe.
A structural commitment to Pixacare's future
Achieving ISO 13485 certification is not an endpoint — it structures our approach to continuous improvement and strengthens our ability to evolve in line with regulatory developments across the medical device sector.
It also reflects the maturity of Pixacare as a digital health company, capable of supporting healthcare institutions in meeting their traceability and quality of care obligations.
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