By the beginning of 2026, we had a finished product that was just a few steps away from mass sales:
- Confirmation of production volumes for equipment reservation with our contractors;
- Adaptation of the prototype to the industrial design;
- Conducting product certification.
The first two points are influenced by the pace and volume of funding, but point three is determined by time only.
Today we will briefly discuss the timing and sequence of the certification we are currently undergoing.
The roadmap consists of 10 key steps.
1. Classification and strategy: 1 month.
2. ISO 13485 Quality System: 4 months (along with items 3–8)
3. Technical documentation (MDR): 4 months.
4. Risk management (ISO 14971): 2 months (along with items 3-5)
5. Software validation (IEC 62304, class C): 3 months (along with item 3)
6. Clinical trials: 6 months.
7. Analytical validation (MARD): 3 months (along with item 6)
8. Biocompatibility (ISO 10993): 2.5 months (along with item 6)
9. Submission of application and audit by the notified body: 3 months (after items 3, 6, 7, 8)
10. Obtaining CE certificate: 3 to 4 months.
Total minimum term (with parallel execution of tasks): ~12 to 15 months.
Currently in progress:
Items 2, 3, 4.
About to be started: item 8.
The MLC team is doing everything possible to meet the planned certification deadline!
Along with certification, we're improving our production approaches, as well as ordering and manufacturing the required production equipment!
By investing in MLC, you are investing in a production facility that is in the final launch stage!
