Quality Policy

At roclub GmbH, 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. Our Quality Policy is built on the following principles:

Customer Focus

We prioritize the needs of our customers and end-users by ensuring our software meets functional, performance, and safety expectations. Customer feedback and post-market surveillance drive continuous improvements in our products and services.

Patient Safety & Security

We integrate risk management, cybersecurity, and usability engineering into our development processes to minimize potential hazards. Our commitment to ISO 13485, MDR, and FDA regulations ensures compliance with global medical device safety and security standards.

Regulatory Compliance & Quality Excellence

We maintain a certified Quality Management System (QMS) aligned with ISO 13485:2016, FDA QSR (21 CFR 820), and MDR 2017/745, ensuring traceability, process control, and regulatory compliance across all operations.

Continuous Improvement & Innovation

We foster a culture of innovation and quality enhancement, utilizing data-driven decision-making and risk-based thinking to drive improvements in product development, supplier management, and customer satisfaction.

Employee Engagement & Responsibility

Every employee at roclub GmbH is responsible for maintaining and improving product quality. We invest in training and development to enhance competency, awareness, and compliance with our quality objectives.

Through these commitments, roclub GmbH ensures the safety, security, and effectiveness of our medical software solutions, delivering high-value products that improve patient outcomes and customer satisfaction.