Isocèle Conseil is looking for experienced consultants
27 Sep.Isocèle Conseil is looking for experienced consultants to enhance the team.
Read moreUpdating of the evaluation of clinical data according to the requirements of Regulation 2017/745
18 Jun. Read moreGuide relative to the «Summary of Safety and Clinical PErformance» (SSCP) – Manufacturers’ Guide – August 19
22 Oct.SUBJECT: 2019-09 – Guide relating to the “Summary of Safety and Clinical Performance” (SSCP) – Manufacturers’ Guide – August 19
Read moreMDCG 2019-8 Guide – Directives relating to implant cards in accordance with article 18 of the MDR
22 Jul.This document has been approved by the Medical Device Coordination Group (MDCG) created by article 103 of EU Regulation 2017/745.
Read moreMDCG 2019-7 Guide – Directives relating to article 15 of the MDR and IVDMDR
15 Jul.SUBJECT: MDCG Guide 2019-7 – Directives relating to Article 15 of the MDR and IVDMDR (In-Vitro Diagnostic Medical Device Regulations) regarding the “Person Responsible for Regulatory Compliance” (PRRC)
Read moreRegulatory Information
11 Jun.TGA Australia – Requirements relating to brochures and implant cards for implantable devices that are and will be available on the market.
Read moreVigilance News
11 Jun.The Post-Market Surveillance and Vigilance Working Group (Sub-Group of the MDCG) has issued an addendum to the MEDDEV Guide 2.12-1 Ver. 8 for compliance with the regulation.
This guide must be used in conjunction with the MEDDEV Guide for vigilance.
Read moreNews 06/05/2019
6 May.Draft Implementing Regulation relating to the common features and application of classification rules for non-medical devices.
Read moreAnalysis of ISO/DIS 14155 standard
17 Jan.Analysis of ISO/DIS 14155 standard (currently being drawn up) – Clinical investigation of medical devices for human subjects — Good clinical practices
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