ISO 13485 certification confirms Pixacare's commitment to meeting the strictest regulatory requirements in medical device development.
Designing a medical device is not enough. Doing so in full compliance with the strictest regulatory standards, at every stage of the product lifecycle, is what ISO 13485 certification guarantees — and what Pixacare has now achieved.
This international recognition confirms our commitment to delivering wound monitoring and telehealth solutions that are reliable, traceable, and fully compliant with applicable standards.
What is ISO 13485 certification?
The ISO 13485 standard is the international reference for quality management systems in organizations involved in the design, production, installation, and maintenance of medical devices.
What it requires in practice
The standard applies across the entire product lifecycle and covers four core requirements: complete traceability of design and manufacturing processes, rigorous risk management, compliance with applicable regulations including European MDR 2017/745, and continuous improvement of the quality management system.
What this certification means for our users?
For healthcare facilities, clinical teams, and patients, ISO 13485 certification provides concrete assurance across three dimensions.
Quality
Every stage of Pixacare's design, development, and commercialization is audited and certified compliant with international requirements.
Reliability
Internal processes are documented, controlled, and reproducible, ensuring a stable and secure user experience over time.
Regulatory compliance
Pixacare meets the obligations imposed on Class I and Class II medical device manufacturers in Europe, under the MDR 2017/745 framework.
A structural commitment to the future
Achieving ISO 13485 certification structures our continuous improvement approach and strengthens our ability to evolve in line with the regulatory developments shaping the medical device industry.
It reflects the maturity of Pixacare as a digital health company, equipped to support healthcare facilities in meeting their traceability and care quality obligations.
Références
- ISO 13485:2016. Medical devices — Quality management systems. International Organization for Standardization, 2016.
- Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR). Official Journal of the European Union.
- DNV. ISO 13485 certification — Medical devices. dnv.com.
