Polish clinical site for device and wound-care trials, with in-house MDR/ISO 14155 support

ETER-MED Sp. z o.o. operates an outpatient healthcare facility in Gdańsk, Poland, alongside a medical device R&D centre in Straszyn. We offer consortia a clinical site that can also absorb the regulatory workload a device trial generates. This offer is independent of our own device programme — we are available as a site for partners' interventions.

Our contribution:

1. Patient access. Recruitment in chronic and hard-to-heal wounds, diabetic foot syndrome and chronic pain.

2. Trial conduct. Investigator-led site operations, on-site quantitative and qualitative data collection including patient-reported outcome measures, with Polish-language translation and cultural validation of instruments.

3. Regulatory and documentation support. Preparation of clinical investigation plans and submissions to the bioethics committee and the Polish competent authority (URPL). We work routinely under EU MDR 2017/745 and ISO 14155 — a capability most clinical sites do not hold in-house.

4. Device-specific capability. Device accountability, safety and incident reporting, and usability/human-factors evaluation under IEC 62366.

5. Regional value. Poland contributes a large Central and Eastern European health system with a high burden of diabetes and chronic wounds, strengthening recruitment rates and generalisability in multi-country proposals.

We are interested in joining consortia that need a Polish site for trials of devices or non-pharmacological interventions, and can additionally support the consortium's regulatory work package.