IVD Assay Development & Contract Manufacturing Services
Future Diagnostics Solutions offers in vitro diagnostic (IVD) assay development and contract manufacturing services to start-up companies, mid-sized biotech and IVD multinationals within the global IVD medical device market. With more than 20 years of experience, 150 IVD product developments and over 50 highly experienced employees, we are dedicated to make any developments, or different phases within the development, successful.
The profound experience makes us a trusted partner for assay development of any type of immuno assay or chemistry test with any type of technology, on any type of analyzer, across any type of disease area.
In general, development and manufacturing in IVD faces challenges resulting from:
• Globalization of operations and supply chains
• Pressure to deliver products to the most cost-effective manner possible
• The need to bring new concepts to market at an ever-faster pace
• Increasing customer expectations for superior quality
These challenges support the need for high level quality management. Future Diagnostics is ISO 13485 certified and integrates its Quality Management System and Design Control Standards within every assay development and manufacturing project. We work according to the needed harmonized standards, EN 13612:2002, EN ISO 23640:2015 and applicable CLSI guidelines.
Future Diagnostics has small to medium scale pilot and commercial production capabilities conform the cGMP requirements for 21 CFR part 820. The manufacturing site is FDA registered (FDA inspections in 2004, 2008, 2011 and 2016).
The customer will be involved during the whole project and will have calls with our experts on a regular basis. They will be updated on technical status, timelines and feedback is given, when needed. In addition, the customer can follow the progress of the project in real time on our SharePoint platform. They can log in onto the secured SharePoint system to review all data that has been produced.
For IVD registration of a product a technical file needs to be set up in compliance with the medical device regulation from a specific country. Future Diagnostics will write a part of the technical file that is needed for the legal registration. The customer will be the legal owner and legal manufacturer of the product. The product will only show the name of customer.
Our customers choose Future Diagnostics Solutions, because we:
- offer both (Immuno) Assay Development and Contract Manufacturing Services.
- work according to cGMP guidelines for IVD (we are ISO13485:2016 certified).
- have a FDA registered manufacturing site.
- are used to working with the most commonly known clinical analyzers.
- are transparent. The progress of each project can be monitored in real time on our SharePoint database.
- are a midsized company (>50 employees, 12 PhD-level). Not too big, but certainly not too small.
- have our focus on developments and manufacturing for third companies.
- developed more than 150 IVD products since 1997.
- have 21 years of experience on a broad range of disease areas, automated platforms, POC platforms and detection technologies.
- have 2 IVD products of our own: Free 25OH Vitamin D (CE-IVD) and STAT IO-I-PTH (CE-IVD/FDA).
"Collaboration between AroCell and Future Diagnostics has led to many product milestones along the way."
Jan Stålemark - CEO AroCell AB
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.