Data Security
Your Data Security Matters to Us
We are committed to protecting the confidentiality and security of all information shared with us. Every report is handled in accordance with the highest data protection standards and applicable regulations related to medical devices and privacy.
Please provide only the information necessary to process your complaint or incident report and ensure that all attached documents are properly anonymized and do not contain patient-identifiable information.
All submitted data is processed exclusively by authorized personnel and solely for the purpose of:
complaint and incident investigation,
product safety monitoring,
regulatory compliance,
continuous improvement of our products and services.
Cormay applies appropriate technical and organizational measures to ensure the security, integrity, and confidentiality of data throughout the entire reporting process.
Data processing is carried out in accordance with:
Regulation (EU) 2016/679 of the European Parliament and of the Council (GDPR),
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR),
applicable national regulations concerning medical devices and post-market surveillance obligations.
We ensure that all personal data and patient-related information are processed with the utmost care and confidentiality. Regardless of the country from which a complaint or incident report originates, we apply the strict data protection and security standards required under the European Union General Data Protection Regulation (GDPR), ensuring an equal and high level of protection for customers both within and outside the European Economic Area.
Submit Your Complaint Quickly and Easily
We are committed to delivering the highest quality products and efficient customer support.
If you notice a problem related to a product, reagent, or device, please submit a complaint using the online form.
How to Submit a Complaint?
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STEP 1
Complete the online complaint form available here [link].
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STEP 2
Provide the necessary information, including:
• product name,
• lot / batch number,
• description of the issue,
• date of occurrence,
• photos or supporting documentation (if applicable). -
STEP 3
Before submitting, make sure all attachments are properly anonymized and do not contain patient-identifiable data.
-
STEP 4
Submit the form — you will receive a confirmation by email.
Reporting Medical Incidents and Adverse Events
Patient safety and the reliability of our medical devices are our top priorities.
If you notice an incident, device malfunction, or any event that may affect patient safety, please report it using the online reporting form.
How to Report an Incident?
-
STEP 1
Complete the online incident reporting form available here [link].
-
STEP 2
Provide the key information:
• product name,
• lot / batch number,
• date of the incident,
• description of the event,
• impact on test results or patient safety. -
STEP 3
Attach supporting documentation only after proper anonymization of all personal data.
-
STEP 4
Submit the form - you will receive a confirmation email.
Data Protection and Confidentiality
Please do not submit sensitive data or documentation containing patient-identifiable information.
All reports are processed in accordance with:
GDPR,
IVDR,
applicable medical device vigilance and post-market surveillance regulations.
Contact
PZ Cormay S.A.
Puławska 303
02-785 Warsaw
Poland