From the first prototype to market registration and day-to-day operation – our team supports you throughout the entire lifecycle of your lateral flow reader. Find downloads, training, documentation and regulatory support in one place.
By your side at every stage
Customer support
Downloads
Find product flyers, certificates, user manuals and the latest software updates for your reader in our download center.
Training & Maintenance
Getting your assay running on our reader should be quick and easy. That’s why every customized system comes with hands-on support.
- Remote training – we help you optimize the reader settings for evaluating your test lines.
- Dedicated project manager – one contact person, backed by an interdisciplinary team, supports your product development.
- Troubleshooting – fast help whenever technical questions come up.
- Maintenance & software updates – ongoing maintenance and timely information about new software releases.
- Webinars & workshops – practical know-how on lateral flow development.
Technical Documentation
Private-label manufacturers receive complete technical documentation for their customized reader system – making it easier to register the product in your target markets.
Developed & manufactured according to ISO 13485:2016
- Complete device documentation for your customized reader system.
- Registration support for your individual target markets.
- Access to our regulatory network for IVDR and FDA requirements.
Regulatory Advice
Bringing a medical device to market requires solid regulatory groundwork. Through our network of experienced regulatory consultants with scientific backgrounds, we support you with submissions under IVDR and to the FDA.
Our consultants can also act as your contact person with the authorities and prepare your quality management system for audits.
Quality Management
Review and improvement of your internal processes.
Market Entry & Risk Management
A clear market entry concept for your medical device.
Technical Documentation
Preparation for registration or approval in each target market.
Still have questions?
Find answers to the most common questions about our readers in our FAQ – or contact your key account manager directly.