Table of Contents - MDR Implementation D

# Workstream Topic Deliverable

Workshops Franklin Lakes &
1 Workshops Presentations
Reading, UK

Final Proposed Corporate Procedure

Working Titles of Proposed Corporate

Post-market Surveillance Procedure

PMS Concept

Overview of PMS Requirements

Final Proposed Risk Management

Corporate Procedure

Risk Management
2 Quality (QM)
Working Titles of Proposed Corporate
Procedure

Final Proposed Usability Corporate

Policy

Usability Final Proposed Usability Procedure

Proposal

Working Titles of Proposed Policy

and Procedure
Reviewed European Vigilance
Vigilance
Procedure

Final Proposed Person Responsibile

Regulatory Compliance
for Regulatory Compliance

Final Proposed Clinical Evaluation

Report - SOP

Working Titles of Proposed SOP

Final Proposed Clinical Evaluation

Report - Template
3 Clinical Clinical Evaluation
3 Clinical Clinical Evaluation

Working Titles of Proposed Template

Questions & Answers

CER Example

Clinical Investigation Comparison

4 Clinical Investigation
Table

Homeworks

MDD-MDR Annexes I, II, III

5 Tech File Tech File Comparison Tool

Tech File Reviews

Contents - MDR Implementation Deliverables by PROSYSTEM
File Name

1_Presentations_Workshops

01_BD_PMS_Proposal_20170509_final

02_BD_PMS_20170217_Prosystem_Draft 01
03_BD_PMS_Draft_20170217_Prosystem Pharm system F Barbotin -
Fred
04_BD_PMS_Draft_20170217_Prosystem Pharm system F Barbotin -
Fred_BG
05_BD_PMS_Draft_20170217_Prosystem_MUC EMEA Quality
06_20170208_PMS concept BD - Requirements &
Interfaces_PROSYSTEM_BG

07_MDR Requirements to PMS

1_CPO-045_RM_Proposal_v2_final

2_CPO-045_RM_Proposal_v1
3_CPO-045_RM_Draft Proposal
4_CPO-045_Draft_RM_v1 hsb comments
5_CPO-045_Draft_RM_v1 fanny
6_CPO-045

1_HF Usability Draft Policy rev 4.2 updated

1_CPR-037_reviewed and commented by Prosystem_BG

1_MDR - Reg Compliance Person_Draft_20170411_BG

BD_SOP_CER_Final Draft_20170530_PROSYSTEM

BD_SOP_CER_Draft 01_20170120_PROSYSTEM
BD_SOP_CER_Draft 01_20170201_BD Review
BD_SOP_CER_Draft 02_20170222_BG_PROSYSTEM
BD_SOP_CER_Draft 03_20170316_SB_PROSYSTEM
BD_SOP_CER_Draft 03_20170419_BD Review
BD_SOP_CER_Draft 04_20170420_SB_PROSYSTEM

BD_Template_CER_Final Draft_20170530_PROSYSTEM
BD_Template_CER_Draft 01_20170120_PROSYSTEM
BD_Template_CER_Draft 01_20170201_Review BD
BD_Template_CER_Draft 02_20170222_BG_PROSYSTEM
BD_Template_CER_Draft 03_20170316_SB_PROSYSTEM
BD_Template_CER_Draft 04_20170404_SB_PROSYSTEM
BD_Template_CER_Draft 04_20170419_Review BD
BD_Template_CER_Draft 05_20170420_SB_PROSYSTEM

BD_clinical workstream_questions

CER example RTF135

Comparison_MDR_ISO_14155_Clinical Investigation_PROSYSTEM

1_Homework

1_Homework/Homework #3/Comparison and Action Items

List_A1_A2_A3_Final

2_Tech Files Review

Deliverables by PROSYSTEM
Summary of Content Person(s) Involved
This folder incorporates workshop material presented during the
Oliver Christ, Berkin Güler, Delvyn
implementation workshops in Franklin Lakes, USA in March
Heinsch, Sandra Bugler (PROSYSTEM)
2017 and in Reading, UK in May 2017

Final proposal for the Corporate Post-market Surveillance

Berkin Güler (PROSYSTEM) & Mark Yale
Prodecure incorporating the MDR's requirements to PMS and
(BD)/ Chuck Fricke (BD)
Post-market Clinical Follow-up

Draft versions of the PMS procedure including commented Berkin Güler (PROSYSTEM) & Mark Yale
versions by the team (BD)/ Chuck Fricke (BD)

This PowerPoint file summarizes the MDR requirements and Berkin Güler (PROSYSTEM) & Mark Yale
drafts a first concept of a PMS procedure (BD)/ Chuck Fricke (BD)
Berkin Güler (PROSYSTEM) & Mark Yale
Summary of PMS requirements
(BD)/ Chuck Fricke (BD)
Final proposal for the Corporate Risk Management Procedure
Berkin Güler (PROSYSTEM) & Daniel
with adjustments to the Risk Matrix; the requirements for
Kim (BD)
Usability Engineering were excluded

Draft versions of the Risk Management procedure including Berkin Güler (PROSYSTEM) & Daniel
commented versions by the team Kim (BD)

Final proposal for a high-level Corporate Usability Engineering

Berkin Güler (PROSYSTEM) & Daniel
Policy incorporating the IEC 62366-1 requirements as well as
Kim (BD)
the guidance provided by the FDA
Final proposal for the more detailed Corporate Usability
Engineering Procedure incorporating the IEC 62366-1 Berkin Güler (PROSYSTEM) & Daniel
requirements as well as the guidance provided by the FDA; this Kim (BD)
version provides more guidance on the how-to
Draft versions of the HF/UE procedure including commented
versions by the team
This PDF contains remarks where the MDR introduces Berkin Güler (PROSYSTEM) & Mark Yale
new/changed requirements (BD)/ Chuck Fricke (BD)
Final proposal for a high-level procedure summarizing the
Berkin Güler (PROSYSTEM) & Randy
obligations of the person(s) responsible for regulatory
McKay (BD)
compliance

This proposed procedure merges the requirements to clinical

Sandra Bugler (PROSYSTEM) & Regina
evaluation reports given in the MEDDEV 2.7-1 rev 4 and the
Haywood (BD)
MDR

Draft versions of the CER SOP including commented versions Sandra Bugler (PROSYSTEM) & Regina
by the team Haywood (BD)

This is the main part of the SOP. The template incorporates

detailed descriptions and guidance for the creation of CER's in Sandra Bugler (PROSYSTEM) & Regina
accordance with the new EU MDR Regulations as well as the Haywood (BD)
MEDDEV 2.7-1 rev 4
Draft versions of the CER template including commented Sandra Bugler (PROSYSTEM) & Regina
versions by the team Haywood (BD)

Questions and answers shared between BD and Prosystem via Sandra Bugler (PROSYSTEM) & Regina
mail Haywood (BD)
This is an example for a CER based on the final CER template Sandra Bugler (PROSYSTEM) & Regina
provided by Prosystem Haywood (BD)

This excel file compares the MDR requirements with those in the Sandra Bugler (PROSYSTEM) &
ISO 14155 Charlene Knape (BD)

This folder contains all three homeworks done throughout the

Delvyn Heinsch (PROSYSTEM) &
project; further information can be found in the provided
Wendy Ballesteros (BD)
presentations for the Tech File workstream
This tool can be found in the Homework #3 folder; this is a
comparison table listing the MDR and MDD requirements for the
Annexes I, II and III (General Safety and Performance Delvyn Heinsch (PROSYSTEM) &
Requirements, Technical Documentation, Technical Wendy Ballesteros (BD)
Documentation PMS), providing fthe possibility to filter by topic
(e.g. risk management, labelling, etc.)
This folder contains reviews of certain tech files provided by BD;
since most of the files are comprised of references to the Delvyn Heinsch (PROSYSTEM) &
required records and documents, the reviews were performed in Wendy Ballesteros (BD)
a low-detail manner
Name Email Phone
Oliver Christ oliver.christ@prosystem-ag.com
Berkin Güler berkin.gueler@prosystem-ag.com
Sandra Bugler sandra.bugler@prosystem-ag.com
Delvyn Heinsch delvyn.heinsch@prosystem-ag.com