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Audit

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Audit Services: Supplier Audits, Internal Audits, ISO 9001 and ISO 13485 certification support and more

Are you looking for an expert service provider for your audits? Whether for supplier audits, internal audits or certification audits, we have the necessary expertise to support you. Our services are tailored to your needs, whether you lack specific in-house skills or want an impartial external view.

 

Our Audit Services

We offer a full range of audit services to ensure that your processes and products comply with current standards and regulations.

 

Supplier/service provider audits

Our supplier audits guarantee the quality and compliance of the products and services provided by your partners. We assess their quality management system according to ISO 9001, ISO 13485 standards and the requirements of European regulations.

 

Internal Audits

Internal audits are essential to identify opportunities for improvement and ensure the compliance of your quality management system. We conduct rigorous internal audits to help you comply with standards such as ISO 13485 and ISO 14971.

 

Support for your Certification Audits

Prepare for your certification audit with our support. We help you comply with ISO 9001, ISO 13485, and regulations specific to medical devices, such as Regulations (EU) 2017/745 and 2017/746.

 

GAP Analysis

We carry out GAP Analyses to assess the gap between your current system and the requirements of standards and regulations. This analysis allows you to target the areas that need improvement in order to achieve compliance.

 

Compliance with Standards and Regulations

Our audits are carried out in accordance with current international standards and regulations, such as:

  • Regulations (EU) 2017/745 and 2017/746: Requirements for medical devices and in vitro diagnostic medical devices

  • ISO 9001: Quality management system

  • ISO 13485: Quality management system for medical devices

  • ISO 14971: Risk management for medical devices

  • IEC 62304: Standard for the software life cycle of medical devices

 

Why choose our company for your audits?

  • Expertise: Our consultants have in-depth experience in the field of quality and regulatory affairs. Certificates of training in auditing techniques according to ISO 19011 and the relevant standards will be sent to you.

  • Independence: As external auditors, we offer an objective and impartial evaluation of your system.

  • Flexibility: We adapt to your needs and constraints to provide a customised audit service.

  • Cost reduction: Outsourcing your audits allows you to control your costs while benefiting from cutting-edge expertise.

 

Contact us

Need a service provider for your audits or a GAP Analysis? Contact us today to discuss your audit and normative and regulatory compliance needs.

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