Medical Device Quality

Providing practical support with the implementation, maintenance and continual improvement of Quality Management Systems aligned with ISO 13485 requirements.

Supporting organisations in understanding and maintaining compliance with applicable European medical device regulations throughout the product lifecycle.

Providing Quality Assurance support to help organisations strengthen quality systems and prepare for applicable FDA requirements.

Supporting the development and continuous improvement of effective Corrective and Preventive Action (CAPA) processes to address issues, identify root causes and prevent recurrence.

Helping organisations establish and maintain effective complaint handling processes that support compliance and continual improvement.

Providing practical support to investigate, manage and resolve non-conformances while strengthening quality processes.

Supporting organisations in developing effective risk management processes that protect product quality and support regulatory compliance.

Helping organisations implement robust change control processes that ensure changes are assessed, approved and managed effectively.

Providing Quality Assurance support throughout every stage of the product lifecycle, from development through to post-market activities.