AUDIT
Supplier of subcontractor Audit
According to the Medical Device Directive, you are also responsible to make sure your crucial subcontractors and suppliers meet the latest standards and regulations. Notified Bodies may visit one of your crucial subcontractors or suppliers if this is likely to ensure more efficient control. The two main issues a Notified Body should address when reviewing subcontractors are:
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Whether the subcontractor is undertaking the supply of a part, material or service, which may affect the compliance of the device with the essential requirements
- Whether the subcontractor has substantial involvement with the design and/or the production of the medical device.
Our consultants can perform a so-called pre-audit which will confirm the regulatory compliance of supplier, or will reveal non-conformities. We help you with the implementation of quality audits and with compliance to international regulations. We have formats, checklists and programs to advise, assist, or carry out the supplier audit, for you.