The Medical Device Blog

nanomaterial

Commission Recommendation on the definition of nanomaterial

By Guillaume Promé
Jun. 15, 2022 Regulation (EU) 2017/745

Definitions of nanomaterial, particle, aggregate, and agglomerate.

HLS: High Level Structure for management system standards

By Guillaume Promé
Jan. 25, 2022 ISO 13485

This article proposes to summarize the High Level Structure for management system standards

5s

5S method

By Guillaume Promé
Jan. 19, 2022 ISO 13485

The 5S method was formalized in the industrial workshops of Toyota, to allow improving the organization of a workspace.

Production Process validation: Cp, Cpk, standard deviation… statistical methods

By Guillaume Promé
Jan. 4, 2022 ISO 13485

Principles and calculations for process validation: capability coefficients, standard deviation, centering, error, number of samples required, etc.

PMCF : Post Market Clinical Follow-up

PMCF: Post-Market Clinical Follow-up for Medical Devices, Guidance

By Guillaume Promé
Dec. 21, 2021 Clinical evaluation, Regulation (EU) 2017/745

Summary of PMCF requirements: Post-Market Clinical Follow-up of medical devices, according to Regulation 2017/745 (definition, methods, expected documents…)

Regulation 2017/745 Guidance

Regulation (EU) 2017/745: guidance for Medical Devices manufacturers

By Guillaume Promé
Dec. 1, 2021 Regulation (EU) 2017/745

Guidance on the implementation of Regulation (EU) 2017/745 on medical devices, particularly for manufacturers.

PSUR: Periodic Safety Update Report for Medical Devices

By Guillaume Promé
Nov. 16, 2021 Regulation (EU) 2017/745, Risk management

Presentation of the Periodic Safety Update Report for medical devices (PSUR) required by the Medical Device Regulation (UE) 2017/745

Cybersecurity

Cybersecurity for Medical Devices

By Guillaume Promé
Nov. 5, 2021 Risk management, Software

This article gives the state of the art in Cybersecurity of Medical Devices, to provide a overall view of a cybersecurity management process.

IEC 62304

IEC 62304 Medical device – Software life cycle

By Guillaume Promé
Oct. 21, 2021 Software

IEC 62304 Medical device – Software life cycle defines the life cycle requirements for medical device software, the set of processes, activities, and tasks described in this standard.

IEC 62366-1

IEC 62366-1 – Medical Devices – Usability Engineering : a Summary

By Guillaume Promé
Oct. 12, 2021 Risk management

Summary of the standard IEC 62366-1 Medical devices Usability engineering: examples and methods.

Comparison of “Notified Body” fees

By Guillaume Promé
Oct. 4, 2021 Regulation (EU) 2017/745

Comparison of “Notified Body” fees in the context of the european regulation on medical devices

Clinical evaluation medical devices

Clinical evaluation of Medical Devices

By Guillaume Promé
Sep. 30, 2021 Clinical evaluation

Introduction to the clinical evaluation of medical devices and corresponding regulatory requirement to obtain and maintain the CE marking

Surveillance apres commercialisation - Dispositifs Medicaux

Post-marketing surveillance (PMS) for medical devices

By Guillaume Promé
Sep. 30, 2021 Regulation (EU) 2017/745

Post-marketing surveillance process and phases

XP S 99-223

[summary] XP S99-223 – Medical Devices – Benefit/risk management

By Guillaume Promé
Sep. 29, 2021 Regulation (EU) 2017/745, Risk management

Summary of the XP S99-223 standard on the management of the benefit/risk ratio of medical devices for regulatory purposes

Roles of the organizations as defined in the Medical Devices Regulation

Roles and obligations in the Medical Devices Regulation

By Guillaume Promé
Sep. 28, 2021 Regulation (EU) 2017/745

Roles and obligations of the Medical Device actors (manufacturer, authorised representative, importer and distributor) in Europe

regulatory watch for medical devices

Doing a Regulatory Watch for medical devices

By Guillaume Promé
Sep. 27, 2021 Regulation (EU) 2017/745

Principles and techniques to perform a regulatory watch, focus on the steps of the process and the means of automation

Quality manual for medical device manufacturer

Quality manual, ISO 13485 and MDR, free template

By Guillaume Promé
Sep. 24, 2021 ISO 13485, Regulation (EU) 2017/745

Quality manual template for medical device manufacturers, according to ISO 13485 and Regulation (EU) 2017/745

ISO 13485:2016+A11:2021

EN ISO 13485/A11: Annex ZA and ZB for regulations 2017/745 and 2017/746

By Guillaume Promé
Sep. 23, 2021 ISO 13485, Regulation (EU) 2017/745

Review of Amendment A11 to EN ISO 13485:2016, containing Annexes ZA and ZB for regulations 2017/745 and 2017/746.

definition medical device

European Definition of “Medical Device”

By Guillaume Promé
Sep. 22, 2021 Regulation (EU) 2017/745

Definition of Medical Device (MD) in the context of the Regulation (EU) 2017/745.

XP-S99-223

XP S99-223:2020 – Medical devices – Benefit/risk management – overview

By Guillaume Promé
Sep. 16, 2021 Risk management

Overview of the XP S99-223 standard