Table 3 Information source, training provider, topic of training, n = 74
Information source for MDR | % | n |
|---|---|---|
Fimea | 83.8% | 62 |
EU websites | 71.6% | 53 |
Medical device consultants | 59.5% | 44 |
Terveysteknologia ry – Healthtech Finland | 33.8% | 25 |
SGS Fimko Oy | 31.1% | 23 |
Other | 24.3% | 18 |
Sailab – MedTech Finland ry | 21.6% | 16 |
Eurofins Expert Services Oy | 20.3% | 15 |
Business Finland | 18.9% | 14 |
Foreign notified body | 16.2% | 12 |
Healthcare incubator or accelerator | 10.8% | 8 |
Training provider regarding the MDR | ||
Fimea | 68.9% | 51 |
In-house training | 54.1% | 40 |
Medical device consultants | 39.2% | 29 |
Terveysteknologia ry – Healthtech Finland | 23% | 17 |
Other | 21.6% | 16 |
Business Finland | 18.9% | 14 |
SGS Fimko Oy | 17.6% | 13 |
Sailab – MedTech Finland ry | 17.6% | 13 |
Healthcare incubator or accelerator | 14.9% | 11 |
Foreign notified body | 13.5% | 10 |
Eurofins Expert Services Oy | 9.5% | 7 |
The topic of training regarding the MDR | ||
To understand the significance of change (from MDD to MDR) | 73% | 54 |
To create a quality management system (EN ISO 13485) | 55.4% | 41 |
To develop a regulatory and registration strategy | 41.9% | 31 |
To understand the differences between different product categories (I–III) | 36.5% | 27 |
For conducting a clinical trial | 32.4% | 24 |
For conducting a usability study | 21.6% | 16 |
To understand the effect of Brexit | 12.2% | 9 |
Other | 12.2% | 9 |
We did not need training | 6.8% | 5 |
To apply for funding for the CE* marking process | 4.1% | 3 |
For EMC** testing | 2.7% | 2 |
For materials research | 1.4% | 1 |