Regulus Medical can:

• provide training in the regulatory requirements for the marketing of medical devices in different countries;
• support companies in achieving quality management system certification to standards or regulations such as ISO 13485, IEC 63204, ISO 27001, the Medical Device Regulations or General Data Protection Regulations;
• design and implement bespoke and operational quality management systems or specific processes within a quality management system;
• maintain an existing quality management system to ensure compliance of processes and their outcomes to applicable regulations, standards, state of the art practice or company policies;
• improve existing quality management systems to increase their effectiveness;
• upgrade quality management systems to incorporate new standard or regulatory requirements.

Regulus Medical can perform specific quality assurance tasks to ensure compliance of processes and their outcomes to applicable regulations, standards, state of the art practice or company policies such as:

• performing gap analysis against specified requirements;
• auditing quality management systems or specific processes.

Regulus Medical can assist with:

• determining optimal regulatory strategies for the introduction of medical products in specific markets;
• planning and preparing regulatory submissions such as 510(k) premarket notifications to FDA or medical device files for review by a EU Notified Body or UK Assessment Body