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Medical Device Quality and Compliance

Ensuring the medical device safety

At roclub, we are committed to developing and delivering high-quality, safe, and secure medical software solutions that meet regulatory requirements, customer expectations, and patient safety needs.

roclub is committed to delivering safe, effective, and high-quality medical devices. Our Quality Management System (QMS) is implemented according to ISO 13485 and supports compliance with FDA and EU MDR regulations, ensuring that our medical devices meet the highest international standards.

Regular Audits and continuous improvement

  • Annual ISO 13485 surveillance audits by our Notified Body (SIQ)
  • Internal audits (per ISO 19011) to maintain compliance and effectiveness
  • Ongoing management reviews and data-driven CAPA processes

Contact Point

For verification of certifications, documentation requests, or compliance inquiries, please contact:
compliance@roclub.com