Have a look to all the services that we provide. We are very transparent in the pricing associated to these consulting services and everything is summarised in the table below.
EU MDR Certification
In the framework EU MDR 2017/745 certification, pricing of the different services that we propose is reported in the table below.
| Class I/Is/Im/Ir | Class IIa | Class IIb | Class III | |
|---|---|---|---|---|
| Preparation of Technical Documentation | 4000 € | 5000 € | 6500 € | 9000 € |
| Identification & Evaluation of applicable standards | Included | Included | Included | Included |
| Labelling & UDI Implementation | Included | Included | Included | Included |
| Risk Management Documentation | Included | Included | Included | Included |
| PMS Plan / PSUR or PMS Report | 1000 € | 1500 € | 2500 € | 3500 € |
| Total | 5000 € | 6500 € | 9000 € | 12500 € |
ISO 13485 Certification
In relation to ISO 13485 certification process, the price for the activities that we can perform are reported in the table below.
| Activity | Price |
|---|---|
| Drafting mandatory procedures and templates. | 1600 € |
| Preparation of Quality Manual | 350 € |
| Preparation of Management Review | 350 € |
| Conduction of Internal Audit, Support during Notified Body Stage 1 and Stage 2 Audit | 2500 € * |
*This price may change depending on the organisation size and the number of days for stage 1 and stage 2 audit. The price includes 1 day Internal Audit, 1 day Stage 1 Audit and 1 day Stage 2 audit.
PMS + PMCF + PSUR
The drafting of Postmarket Surveillance Plan / Postmarket Clinical Follow-Up / Periodic Safety Update Report
| Activity | Class I/Is/Im/Ir | Class IIa | Class IIb | Class III |
|---|---|---|---|---|
| PMS / PSUR / PMCF | 1650 € | 1950 € | 2800 € | 4000 € |
Clinical Evaluation
| Activity | Class I/Is/Im/Ir/IIa | Class IIb | Class III |
|---|---|---|---|
| – Preparation of Clinical Evaluation Plan – Literature Search according to the methodology defined in the Clinical Evaluation Plan – Documentation of the results of the literature search – Demonstration of equivalence (if required). – Data Appraisal and Analysis – Preparation of Clinical Evaluation Report | 4500 € | 6500 € | 8000 € |
