Quality Policy

At EUmAccess GmbH, we are committed to delivering high-quality regulatory and compliance services that meet the stringent requirements of ISO 13485 and ensure the highest standards of safety, efficacy, and reliability for medical devices and in vitro diagnostic (IVD) products.

Our quality policy is built on the following core principles:

• Regulatory Compliance: Ensuring full adherence to applicable EU MDR (2017/745), IVDR (2017/746), and ISO 13485 standards to facilitate seamless market access for our clients.
• Customer Focus: Understanding and fulfilling our clients' needs by offering tailored solutions that enhance regulatory compliance and product quality.
• Continuous Improvement: Maintaining a culture of ongoing enhancement in our processes, services, and knowledge to keep pace with evolving regulations and industry best practices.
• Risk-Based Approach: Implementing proactive risk management strategies to identify and mitigate potential compliance challenges for our clients.
• Competence & Training: Equipping our team and clients with the necessary knowledge and expertise through training programs to uphold the highest quality standards.
• Process Efficiency: Ensuring the effectiveness of our quality management system (QMS) by regularly monitoring, reviewing, and improving our operational procedures.

We at EUmAccess GmbH are dedicated to upholding these principles to support our clients in achieving and maintaining regulatory excellence while contributing to patient safety and public health.