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Scientist

QUALITY & REGULATORY SERVICES FOR MEDICAL DEVICES AND IVDs

QUALITY SERVICES FOR MEDICAL DEVICES

 

ISO 13485 FOR MEDICAL DEVICES

Quality and Regulatory requirements in the Medical Device industry can be challenging for the organisations. IVDEXEL is the best partner to help you with a Quality strategy to align the the processes of your Quality Management System.

How can IVDEXEL assist your organization?

  • Implementation of the QMS

  • Implement the Risk management System (RMS)

  • Gap analysis for QA/RA

  • Internal Audit programs

  • Management Review

  • Avoid major NC

  • Selection of appropriate technical standards  for your industry and products.

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ISO 14971 FOR RISK MANAGEMENT

The experience showed that a high percentage of Manufacturers do not apply the Risk Management System to meet the requirements of the ISO 14971. IVDEXEL will help you understand the impact of ISO 14971:2019 on the decision-making processes when manufacturing Medical Devices.

IVDEXEL will help you:

  • Identify the key requirements of ISO 14971:2019.

  • Support with your Risk Management Policy.

  • How to communicate the key requirements and expectations of ISO 14971:2019 to your organization.

  • Gain knowledge on how ISO 14971:2019 links to ISO 13485 and the regulations.

  • Apply the fundamental risk management activities for Medical Devices within your organization.

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ISO/TR 20416 FOR POST-MARKET SURVEILLANCE

How can IVDEXEL help you:

  • How to integrate the PMS and vigilance processes into the QMS and product life-cycle.

  • How to understand the main concepts and requirements of the post post-market surveillance and vigilance.

  • How to communicate the impact of key requirements in your organization.

  • To use essential tools to implement a compliant post-market surveillance and vigilance for different jurisdictions.

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REGULATORY SERVICES FOR MEDICAL DEVICES

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MDR and IVDR Regulations (EMA)

Our consulting services are designed to help your company comply with the new EU MDR/IVDR regulatory requirements, which may involve securing a CE Mark via the EU Notified Body. We provide training to ensure your team comprehends how these regulations affect your products, as well as guidance on preparing technical documentation and advanced tools for post-market surveillance and vigilance. Additionally, our services encompass impact assessments, gap analyses, and assistance with submitting technical documentation, UDI, PMS, and clinical evidence to the Notified.

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Medical Devices and IVDs Regulation in Australia (TGA)

We provide consulting services for the medical device sector in Australia. Our team offers technical assistance with documentation and TGA requirements. We focus on the registration of medical devices and in vitro diagnostics, ensuring adherence to regulatory standards. Reach out to us today to discover more about our services.

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Medical Devices and IVDs Regulation in the US market (FDA)

Our team specializes in providing technical support with documentation and FDA regulations. We concentrate on Premarket Notification (510(k)) and Premarket Approval (PMA), ensuring compliance with regulatory standards. Contact us today to learn more about how we can assist you.

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