Safeguarding data per GDPR regulations, offering secure handling of personal data for enhanced privacy protection.
Read from the sourceOur solution aligns with the latest rules on electronic IFU for medical devices, ensuring MDR compliance.
Read from the sourceAddressing electronic instructions for use of medical devices as per MDD requirements.
Read from the sourceAligning with the Medical Devices Regulation, our solution ensures compliance with the latest EU directives.
Read from the sourceOur eIFUApp complies with the In Vitro Diagnostic Medical Devices Regulation, streamlining adherence to Directive 98/79/EC.
Read from the sourceProviding streamlined eIFU solutions tailored for In-vitro Diagnostic Medical Devices compliance.
Read from the sourceAddressing compliance with the Federal Food, Drug, and Cosmetic Act – Chapter V for Drugs and Devices, ensuring eIFU adherence.
Read from the sourceEnsuring compliance with U.S. Code, Title 21, Chapter 9, subchapter V, Part A, §352 on labeling and advertisements for drugs and devices.
Read from the sourceEnsuring compliance with U.S. Code, Title 21, Chapter 11 on electronic records and signatures.
Read from the sourceComplying with Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA) for electronic labeling of prescription devices in health care facilities.
Read from the source