Quality Assurance & Regulatory Affairs

Quality is a fundamental framework that creates better outcomes. Our clients, partners, and stakeholders can have the utmost confidence that we not only deliver quality but also maximise valuable outcomes.

Certification and compliance:

• + ISO 13485 - quality management medical devices

• + ISO 14971 - risk management medical devices

• + IEC 62304 - medical device software

• + IEC 62366 - usability engineering medical devices

• + IEC 60601 - medical electrical equipment

Regulatory affairs is about navigating the complex landscape of medical device regulatory requirements through an entrepreneurial lens.

How we do it

• Tailored Solutions

• Global Perspective

• Comprehensive Expertise

• Strategic Partnerships

• Regulatory Intelligence