Services

Gap assessments

A clear review of where your current system stands against ISO 9001 or ISO 13485, with a practical action plan.

QMS setup and implementation
Building your quality management system from the ground up, including your quality manual, procedures, forms and records.

Document control and SOPs
Writing, updating and organising your procedures so they are easy to follow and audit ready.

Internal audits
Independent internal audits to find gaps before your certification body does.

SAHPRA licence support
Help with preparing documents for a medical device establishment licence.

Staff training
Practical training so your team understands the system and their role in it.

Not sure what you need? Get in touch for a free first conversation.

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