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4EasyReg is an online platform dedicated to Regulatory matters within the medical device, information security and AI-Based business.
We offer a wide range of documentation kits to support your compliance efforts towards a wide range of standards and regulations, such as ISO 13485, EU MDR, ISO 27001, ISO 42001 and much more. . Specifically, in our webshop you will find:
- ISO 13485 Documentation / Compliance Kit
- ISO 27001 Documentation / Compliance Kit
- ISO 42001 Documentation / Compliance Kit
- FDA Cybersecurity Documentation
Within our sister platform QualityMedDev Academy, a wide range of online & self-paced training courses is available, such as for example:
- Complaint Handling and Vigilance Reporting
- Artificial Intelligence in Medical Device. Regulatory Requirements
- Unique Device Identification (UDI) Requirements according to EU MDR
- Clinical Evaluation Process According to EU MDR
- Medical Device SW Verification & Validation
- Risk Management for Medical Devices
- Usability Evaluation for Medical Devices
As one of the leading online platforms in the medical device sector, 4EasyReg offers extensive support for regulatory compliance. Our services cover a wide range of topics, from EU MDR & IVDR to ISO 13485, encompassing risk management, biocompatibility, usability, software verification and validation, and assistance in preparing technical documentation for MDR compliance.
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