From the idea to the ready-made IVD test kit – Senova accompanies customers through all phases of product implementation. Our modular product development plan transparently leads to marketable products. The creation of the supporting documents results in the technical documentation (TD) at the end.
|Development phase||supporting documents|
|Initial phase||product development team, product file master product, product development history, checklist analytical parameters, checklist technical (design) parameters, checklist clinical parameters, release document, checklist compliance requirements DIN EN 14971, FMEA part technical (design) parameters, FMEA part Clinical parameters|
|Degree of certification||list of product variants, checklist requirements QM|
|Feasibility phase||product development history, FMEA part of test strips and bioreagents, checklist accordance of analytical parameters with clinical parameters for approval|
|Implementation phase||product development history, FMEA part of test strips and bioreagents , FMEA part kit components and labeling, FMEA part test implementation and test limits, FMEA part user, patient, third party FMEA part production and testing, checklist accordance of analytical parameters with clinical parameters for approval, checklist accordance of technical parameters for approval, cost calculation|
|Usability study||plan, questionnaire, protocol, report, FMEA part user|
|Pilot production phase||design and manufacturing information, list of all production instructions (HA) and QC instructions (PA), list of all components, list of labels, print templates, layouts, list of all suppliers, creation of all product data sheets, declarations of no objection and batch certificates, visual production and test presentation|
|Performance evaluation||evaluation plan, evaluation protocols, evaluation report – includes scientific validity, analytical and clinical performance, flex study and investigation of transport influences|
|Stability studies||stability plan, stability protocol, stability report for real-time durability and transport stability testing|
|Product launch||risk management report with residual risk assessment, technical documentation, operating instructions, conformity assessment procedure (authority review)|
|Post market||plan post market, protocol post market, report post market
We are always interested in innovative topics that enrich the IVD diagnostics market.