Project management

Milestone-driven project management

Milestone-driven project execution and an ISO 9001 & 13485 compliant design control process both lead to a straightforward product realization: From project start over design goal, design input, design output to product launch. Microcoat establishes comprehensive quality controls to guarantee customers satisfaction. Our complain system supports customers in the processing of problems occurring at the end user. Customer audits are a common practice to us. Progress is constantly monitored and reported throughout the entire course of a project.

Our Standards

All assay development service projects are performed under the rules of ISO and if requested according to IVD regulations. Assay validation can be additionally performed following GLP guidelines.

Development steps

Feasibility and development
Assessment of reagents
Initial performance characteristics
Sample preparation protocols
Optimization
Assay design
Components
Concentration
Workflow
Quality controls
Development of production
Final kit design
Upscaling
Primary and secondary packaging
Prototype lots
Stability testing

See also:

Did you know...

... that Microcoat produces more than 1 million lateral flow tests per year ?

Did you know...

... that Microcoat produces up to 1 Million lateral flow tests per year ?

Partnerships

Based on our broad network of suppliers and scientific partners we offer modern solutions with highest quality

Partnerships

Based on our broad network of suppliers and scientific partners we offer modern solutions with highest quality

Developer of diagnostic platforms

Rely on our third party benchmarking and supporting technology evaluation services

Developer of diagnostic platforms

Rely on our third party benchmarking and supporting technology evaluation services