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Software Development Plan According to IEC 62304:2006 Vigilance Reporting Requirements according to EU MDR 2017/745 PRRC (Person Responsible for Regulatory Compliance) and the EU MDR. ISO 11167 : Requirements for Sterile Medical Device Packaging Periodic Safety Update Report (PSUR) according to EU MDR 2017/745
IEC 62304

Software Development Plan According to IEC 62304:2006

Feb 26, 2021 QualityMedDev
post market surveillance

Vigilance Reporting Requirements according to EU MDR 2017/745

Feb 25, 2021 QualityMedDev
EU MDR 2017/745

PRRC (Person Responsible for Regulatory Compliance) and the EU MDR.

Feb 22, 2021 QualityMedDev
Packaging

ISO 11167 : Requirements for Sterile Medical Device Packaging

Feb 18, 2021 QualityMedDev
EU MDR 2017/745 post market surveillance

Periodic Safety Update Report (PSUR) according to EU MDR 2017/745

Feb 16, 2021 QualityMedDev
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  • IEC 62304
    Software Development Plan According to IEC 62304:2006
  • post market surveillance
    Vigilance Reporting Requirements according to EU MDR 2017/745
  • EU MDR 2017/745
    PRRC (Person Responsible for Regulatory Compliance) and the EU MDR.
  • Packaging
    ISO 11167 : Requirements for Sterile Medical Device Packaging
  • Medical Device Risk Management
    New ISO 14971: Updates for Risk Management
  • Labelling Manufacturer Medical Device
    ISO 20417 : New ISO Standard on Information to be Provided by Manufacturer
  • QMS statistic V&V Validation Verification
    Statistic for Quality Management Systems: ISO and FDA Requirements
  • Eudamed
    Eudamed Database for Medical Devices in Europe: EU MDR requirements
  • IEC 62304
    Software Development Plan According to IEC 62304:2006
  • post market surveillance
    Vigilance Reporting Requirements according to EU MDR 2017/745
  • EU MDR 2017/745
    PRRC (Person Responsible for Regulatory Compliance) and the EU MDR.
  • Packaging
    ISO 11167 : Requirements for Sterile Medical Device Packaging

Posts List

  • EU MDR 2017/745
    PRRC (Person Responsible for Regulatory Compliance) and the EU MDR.
  • EU MDR 2017/745 post market surveillance
    Periodic Safety Update Report (PSUR) according to EU MDR 2017/745
  • EU MDR 2017/745 post market surveillance Uncategorized
    The PMCF (Post-Market Clinical Follow-Up) according to EU MDR 2017/745
  • Combination product EU MDR 2017/745
    Combination Products and EU MDR 2017/745 Regulation
  • Change Control EU MDR 2017/745 TGA
    Change Control Process
IEC 62304

Software Development Plan According to IEC 62304:2006

Feb 26, 2021 QualityMedDev

The development of software for SaMD (Software As Medical Device) and SiMD (Software In Medical Device) is regulated through a specific standard named IEC 62304 - Medical device software —

post market surveillance

Vigilance Reporting Requirements according to EU MDR 2017/745

Feb 25, 2021 QualityMedDev

Introduction Vigilance reporting is one of the pillars of post-market surveillance process for medical device. It belongs to the so-called “passive” methods of post-market surveillance activities, as basically the manufacturer does

EU MDR 2017/745

PRRC (Person Responsible for Regulatory Compliance) and the EU MDR.

Feb 22, 2021 QualityMedDev

The PRRC (Person Responsible for Regulatory Compliance) is one of the new requirement of the EU MDR European Medical Device Regulation and In-Vitro Diagnostic Regulation 2017/745 and 2017/746. The requirements

Packaging

ISO 11167 : Requirements for Sterile Medical Device Packaging

Feb 18, 2021 QualityMedDev

ISO 11167 plays a fundamental role in the requirements related to packaging for sterile medical device. The design of packaging which is able to maintain sterility of the device through

EU MDR 2017/745 post market surveillance

Periodic Safety Update Report (PSUR) according to EU MDR 2017/745

Feb 16, 2021 QualityMedDev

One of the new requirement introduced with the EU MDR 2017/745 is the one related to the preparation of the Periodic Safety update Report (PSUR). This type of report is

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  • Software Development Plan According to IEC 62304:2006
  • Vigilance Reporting Requirements according to EU MDR 2017/745
  • PRRC (Person Responsible for Regulatory Compliance) and the EU MDR.
  • ISO 11167 : Requirements for Sterile Medical Device Packaging
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You missed

IEC 62304

Software Development Plan According to IEC 62304:2006

Feb 26, 2021 QualityMedDev
post market surveillance

Vigilance Reporting Requirements according to EU MDR 2017/745

Feb 25, 2021 QualityMedDev
EU MDR 2017/745

PRRC (Person Responsible for Regulatory Compliance) and the EU MDR.

Feb 22, 2021 QualityMedDev
Packaging

ISO 11167 : Requirements for Sterile Medical Device Packaging

Feb 18, 2021 QualityMedDev

QualityMedDev

QMS & Medical Device Regulation

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