IVD & Medical device compliance audits

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eQMS diagram

PharmOut is privileged to have several consultants who have years of experience as TGA and PIC/S auditors.

They know the relevant international regulatory codes for Medical Devices (with IVDs being a subcategory) e.g. QSR 820, ISO 13485, ISO 14971 and the GHTF QMS (IMDRF) for medical devices.

If you are exporting medical devices to multiple countries that use different regulatory frameworks, we can help you achieve compliance in a practical way, rather than drowning yourself in paperwork.

If you are soon to be audited by a Notified Body or a regulator, or want to ensure you are still compliant after major change, we offer two audit services to assess your compliance to the appropriate codes.

On-site Mock ISO 13485 Audits / Medical Device Compliance Audits

A mock ISO 13485 audits involves:

  • A Consultant visiting your site for 2-3 days, just like a regulatory auditor.
  • Working with you to create a checklist, appropriate for the type of site and that includes typical sources of non-compliance and the areas you want covered.
  • Visually inspecting the site, asking questions and requesting evidence to prove you are following your procedures and meeting regulatory requirements.
  • Compiling a report of audit findings. The consultant will also include improvement recommendations if required

Hot tip – If the auditor is following your internal company procedure, they must be trained in accordance with your company QMS. 

A Mock Medical Device GMP Audit is often used to get management attention and resources before a regulatory audit.

Desktop Medical Device Compliance Audits

A cheaper option is a TGA style desktop audit, our consultants use the Desktop Audit format developed by the Australian TGA. This format is also used by some other international regulatory authorities.

A Medical Device Desktop Compliance Audit involves:

  • You supplying key QMS documents e.g. your validation master plan and product release records to the auditor.
  • The auditor reviewing the documents for regulatory compliance.
  • The auditor then calling you for clarification on any problems they find. This might require other documents to be supplied.
  • Once all issues have been discussed, the auditor will compile a final report that you can then use to determine your course of action.

More Information

If you would like a quote or would need to ask questions, please contact us.