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In-Vitro Diagnostics Consulting.

Our specialized consulting services help you to develop innovative diagnostic solutions efficiently and safely.

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Precise?

Do you develop reliable diagnostic solutions that meet market requirements?

Are you sure?

Do you ensure compliance with all regulatory requirements globally?

Successful?

Would you like to accelerate your market launch and ensure long-term success?

Successful IVDR approval!

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IVD Consulting.

Our specialized IVD consulting services offer you tailor-made support to develop innovative diagnostic solutions efficiently and safely and to meet the strict IVDR requirements.

In vitro diagnostics plays a crucial role in modern medicine and is a growing sector with constantly new technological and regulatory requirements. The development of new diagnostic products is subject to stricter guidelines, particularly due to the introduction of the IVDR in the European Union. Companies in the IVD industry must ensure that their products and processes comply with the latest regulatory requirements to ensure market access.

We support you with comprehensive advice in the areas of regulation, process optimization and innovation management. Our expertise helps you to master the challenges of IVDR compliance while optimizing your production and development processes. With a clear focus on technology transfer and product validation, we ensure the smooth market launch of your diagnostics solutions.

Our consulting services also include support with CE marking, FDA approvals and other global standards. In addition, we help you to develop innovation strategies that ensure the market success of your products and future-proof your company.

Optimized solutions for your in-vitro diagnostics.

Our specialized consulting services support you in optimizing your diagnostics processes, overcoming regulatory hurdles and driving innovation.

Regulatory compliance.

  • Support for the global approval of IVD products.
  • Compliance with international regulations and standards.
  • Advice on CE marking and FDA approval.
  • Risk management to avoid regulatory pitfalls.

Product and process validation.

  • Ensuring product integrity through comprehensive validation processes.
  • Review and optimization of production processes.
  • Carrying out quality control tests.
  • Implementation of measures for continuous improvement.

Technology and innovation consulting.

  • Development and implementation of innovation strategies.
  • Support with the integration of new technologies.
  • Analysis of market trends to identify new opportunities.
  • Strategic consulting to strengthen your market position in the field of in-vitro diagnostics.

Successful projects in IVD.

Our case studies in in-vitro diagnostics.

Challenge.

An international supplier of IVD products was planning to enter the US market and had to overcome extensive regulatory hurdles, including stringent FDA regulations.

Measures.

  • Carrying out comprehensive due diligence to assess FDA requirements.
  • Development of a customized FDA approval strategy.
  • Analysis of the US market and development of a positioning strategy.

Results.

  • Successful FDA approval within 18 months.
  • Reduction of market entry time by 30%.
  • Sales growth of 20% in the first year after market entry.

Success.

The company successfully entered the US market and achieved FDA approval in a very short time.

Bring your IVD products safely to market!

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Our IVD Consulting services at a glance.

Our IVD Consulting Services offer you comprehensive support in all areas that are crucial for the development, approval and market success of your in-vitro diagnostics.
Our regulatory experts help you to ensure global market access for your in-vitro diagnostics. This includes support in complying with IVDR requirements in the European Union, CE marking and FDA approval in the USA. We also advise you on other international standards and guide you through the entire approval process. Our focus is on identifying potential regulatory risks at an early stage and developing solutions that ensure your compliance and bring your products to market quickly and safely.
To ensure the success of your products, we analyze and optimize your development and production processes. Our tailor-made solutions help you to increase efficiency, reduce costs and ensure the quality of your products. We support you in the implementation of continuous improvement processes and carry out comprehensive validations to ensure the integrity of your products and processes. In this way, we ensure that all regulatory requirements are met and that your production processes run smoothly.
Innovation is crucial for success in the IVD sector. We support you in the development of new diagnostic solutions and the implementation of state-of-the-art technologies to strengthen your competitiveness. Our technology transfer service ensures that your innovations are successfully transferred from development to production. From feasibility analysis to validation of production, we offer you comprehensive support to ensure that your products are ready for the market and meet all quality requirements.
Implementing a robust quality management system (QMS) is essential for ensuring product quality and safety. Our experts support you in implementing QMS according to international standards such as ISO 13485 and conduct regular quality checks to ensure that your processes meet the highest standards. In addition, we offer you support in preparing for audits and inspections so that you meet the strict requirements of the regulatory authorities.
Integrating digital technologies into your diagnostic processes offers numerous advantages. We help you to integrate digital solutions such as data analysis, automation and machine learning into your production and development processes. With our technology consulting, we optimize your processes and ensure that you use the latest trends and innovations to improve your diagnostic solutions and make them more efficient. We also support you in the digitalization of your quality controls and the introduction of systems for real-time monitoring of production data.

Optimize your IVD processes.

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