Which regulations show I care?
EU - GDPR Compliance
Safeguarding data per GDPR regulations, offering secure handling of personal data for enhanced privacy protection.
Read from the source →EU - MDR Regulation 2021/2226
Our solution aligns with the latest rules on electronic IFU for medical devices, ensuring MDR compliance.
Read from the source →EU - MDD Regulation No 207/2012
Addressing electronic instructions for use of medical devices as per MDD requirements.
Read from the source →EU - MD Regulation 2017/745
Aligning with the Medical Devices Regulation, our solution ensures compliance with the latest EU directives.
Read from the source →EU - IVD Regulation 2017/746
Our eIFUApp complies with the In Vitro Diagnostic Medical Devices Regulation, streamlining adherence to Directive 98/79/EC.
Read from the source →EU - IVDs (MEDDEV 2.14/3 rev.1)
Providing streamlined eIFU solutions tailored for In-vitro Diagnostic Medical Devices compliance.
Read from the source →US - FDA eIFU Compliance (FD&C Act)
Addressing compliance with the Federal Food, Drug, and Cosmetic Act – Chapter V for Drugs and Devices, ensuring eIFU adherence.
Read from the source →US - FDA Labeling & Advertisement Compliance (U.S. Code, Title 21, Chapter 9)
Ensuring 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 source →US - FDA Electronic Records & Signatures Regulation (U.S. Code, Title 21, Chapter 11)
Ensuring compliance with U.S. Code, Title 21, Chapter 11 on electronic records and signatures.
Read from the source →US - FDA Authorization for eIFU (MDUFMA)
Complying with Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA) for electronic labeling of prescription devices in health care facilities.
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