Audit
Medloft experts with Notified Body expertise provide second party audit services. These services cover on-site and remote audit. Before your certification audit by a third-party organization, you may benefit from our audit services to have a final review of your technical files or quality management system.
Planning
The audit scope is defined during the audit planning stage. Medloft experts with Notified Body experience can support you in
- Mock-up Audit
- Critical supplier/subcontractor audit
- Internal Audits
The Mock-up audit will reflect your status according to the applicable regulation or standard (such as ISO 13485, MDR,IVDR). In addition to this you can benefit from supplier/subcontractor audit services to ensure that your subcontractor is ready for a certification audit. On the other hand, if you are a small company with limited QA&RA resources, you may outsource your internal audit process to a dedicated Medloft Expert.
Our experts will define a detailed audit criterion for your audit using a risk-based approach. This can be a whole standard like ISO 13485, FDA CFR 21 Part 820 or a regulation such as MDR EU 2017/745, IVDR EU 2017/746 or parts of those. In this way, you will have an effective custom-made report according to your project needs.
Remote & On-Site Audit Services
Our expert auditors will perform the on-site or remote audit according to the audit plan. With today’s video conference tools, remote audits provide tremendous advantages for time management, social distancing and cost-effectiveness. Our Auditors will use a process approach and sampling method based on the requirements of ISO 19011 standard. During the audit process, they will collect all objective evidence and compare them with the audit criteria.
Reporting
Our experts will prepare a detailed audit report, which will show you the pros and cons of your quality management system and medical device. The non-conformities will be reported in a professional way and reference clear objective evidence. In this way, you can plan your corrective actions in a clear and structured way. If needed, our experts will discuss possible corrective actions in order to comply with the requirements.
Review of the Corrective Actions
After your team implemented the planned corrective actions, MEDLOFT experts will support you in reviewing the effectiveness of the results. They will plan a follow-up audit and review the status of the findings. As required by the applicable standards and regulations this review will do under a risk-based approach. If applicable, our experts will define additional control measures with your team.
