Audit

Companies in the medical devices industry must adhere to strict quality standards and regulations, such as the requirements of Article 10 of Regulation (EU) 2017/745, ISO 13485, or MDSAP. 

 

A deficiency in meeting a requirement can impact the safety, effectiveness, and quality of products and processes. Therefore, it is necessary to periodically monitor compliance with these requirements. 

 

Our audits are not merely a response to a checklist to identify non-conformities; they take into account the company's context, the level of process interaction, and aim to seek compliance. Our policy is to promote mutual information exchange during the audit, providing practical advice on how to manage a non-compliant situation.

 

Utilize our field experience for:

 

• Internal Audits: essential for verifying compliance levels, identifying improvement opportunities, documenting improvements made, and identifying areas of concern.
  

• Remote Audits: while in-person activities are preferred, we have learned that certain situations, such as distance, budget constraints, and time limitations, sometimes require a different approach. We are equipped with technology and experience to conduct remote audits and will provide guidelines to be prepared for remote audit support.

• Supplier Qualification Audits: it is a company's duty and responsibility to ensure that suppliers are kept under control, especially when they perform activities on behalf of the company (outsourcing). We apply our policy to ensure continuous compliance with agreed-upon supplier requirements and help the company identify critical suppliers.

• Audits of Distributors, Importers and Authorized Representative: regulation (EU) 2017/745 imposes specific requirements on distributors, importers, and mandators based on their roles and assigned responsibilities. We help the company raise awareness of compliance with requirements through our audits.

• Document Audits and Gap Analysis: it is useful to identify areas for improvement at the beginning of the implementation of a quality management system or technical documentation. These audits allow us to prepare an action plan and intervention scheduling to achieve the objective.
  

 

Why FTR ADVISOR? Because our team consists of experienced auditors who promote mutual communication and support their comments and observations with practical advice.