More on our Services

MANAGEMENT SYSTEM CONSULTING

Establishing a management system in compliance with one or more of the following management system standards / guidelines:

• ISO 13485 Quality Management System for Medical Devices 

• FDA 21 CFR Part 820

• ISO 27001 Information Security Management System 

• ISO 27701 Privacy Management Systems

• ISO 42001 AI Management Systems

• AS9100 Quality Management system for Aviation, Space and Defense

• ISO 9001 Quality Management Systems

Typical implementation process:

• Understand the scope of the project.

• Set up a Project Plan to facilitate the implementation and review the project progress.

• Work with the process owner to define and implement business processes integrated with the relevant standard’s requirements.

• Train process owners (as required).

• Get quotes from Certification / Notified Bodies to perform the External Audit.

• Perform Internal Audits and Management Review (as required).

• Assist during External Audit (as required).

Product / service Compliance Consulting

We would love to assist you if your product / service needs to be in compliance with local or international regulations to ensure easy access to market. We have a vast amount of experience on compliance requirements relating to:

• Medical Device and general product compliance regulations e.g.:

  • EU Directives for CE marking (e.g. MDR) 

  • FDA approval (including 510k, PMA)

  • SAHPRA

  • etc.

• Other EU Directives for CE marking (e.g. Machinery etc.)

• Alignment of your management system with local and international privacy regulations e.g.

  • GDPR

  • POPI

  • etc.

Typical implementation process:

• Understand the scope of the project.

• Set up a Project Plan to facilitate the implementation and review the project progress.

• Work with the technical team to establish the technical file or required system controls.  

• Train process owners (as required).

• Get quotes from Certification / Notified Bodies to perform the External Audit.

• Perform Internal Audits (as required).

• Assist during External Audit (as required).