Quality Management is the act of overseeing all activities and tasks needed to maintain a desired level of excellence. REAF Consulting can assist Medical Device companies to achieve this by providing consultation on:

 

Quality Management Systems- (QMS)

• Gap analysis: An assessment of the organization’s existing quality management system to identify areas where it does not meet the requirements of the ISO 13485 standard.
• Documentation development: Assistance in the development of documents required for a compliant quality management system, such as policies, procedures, and work instructions.
• Implementation support: Support in implementing the QMS, including training and coaching on best practices.
• Internal auditing: Conducting internal audits to ensure that the QMS is being followed and to identify areas for improvement.
• Certification support: Assistance with the certification process, including preparation for the certification audit.

 

SAHPRA Licensing

Provide support and assistance for Medical Device Licensing with the South African Health Products Regulatory Authority (SAHPRA).

 

CE Marking

We provide guidance and support to companies seeking to comply with the European Union’s (EU) regulations for product safety and conformity.