IVD Assay Development & Contract Manufacturing Services

At Future Diagnostics, we know that there is a difference between an assay and a product. We all come to work every day because we want to assist our customers to transform an assay to an IVD product. By assisting you we can accelerate your product launch. We make use of our ample knowledge and expertise in respect to the entire process of product development from research to a RUO to a CE-IVD/FDA product.

Our customers choose Future Diagnostics Solutions, because we:

  1. offer both (Immuno) Assay Development and Contract Manufacturing Services.
  2. work according to cGMP guidelines for IVD (we are ISO13485 certified).
  3. have a FDA registered manufacturing site.
  4. are used to working with the most commonly known clinical analysers.
  5. are transparent. The progress of each project can be monitored in real time on our SharePoint database.
  6. are a midsized company (60 employees, 12 PhD-level). Not too big, but certainly not too small.
  7. have our focus on developments and manufacturing for third companies.
  8. developed more than 150 IVD products since 1997.
  9. have 20 years of experience on a broad range of disease areas, automated platforms, POC platfoms and detection technologies.
  10. have 2 IVD products of our own: Free 25OH Vitamin D (CE-IVD) and STAT IO-I-PTH (CE-IVD/FDA).

Customers:

"Collaboration between AroCell and Future Diagnostics has led to many product milestones along the way." 

Jan Stålemark - CEO AroCell AB

"The employees of Future Diagnostics are strongly involved in the entire project." 

Guus Scheefhals - CEO Crossbeta B.V.

Have a look at customers we work(ed) with: www.future-diagnostics.com/references/

Future Diagnostics Solutions B.V. is an independent, internationally oriented and certified service provider focused on the medical diagnostics and device industry. Our modern, state-of-the-art laboratory is based in Wijchen, The Netherlands, which is located in the Dutch Health Valley area since 1997.

Future Diagnostics believes that exceeding customers’ expectations is realized by continuous improvement and applying our core values:

Integrity, Teamwork, Customer Focus, Organizational Sensitivity

We have the flexibility to incorporate ideas and technologies from any source to create the best solutions.

 


 

Mike Klinkenberg

MSc, Managing Director

Mike Martens

PhD, Scientific Director

Ernst Lindhout

PhD, Director Research and Development

Henny Pit

Director Operations