820 MDR DOCUMENT REQUIREMENT

Phase 0 - Feasibility
R A2100X-01 Needs Assessment
A2100X-02 Feasibility Study and Report
R a. Regulatory Assessment
R b. Quality Assessment (SQE, QA, etc.)
R c. R&D Assessment
R d. Marketing Assessment
R e. Purchasing Assessment
R f. Distribution Assessment
R g. Sustaining Engineering Assessment
R h. Operations Assessment
R i. Finance Assessment
R j. Clinical Assessment
R k. Legal Assessment (IP)
R R B2100X-01 Executive Mgt Approval & Code
Phase 1 - Planning
B2100X-02 Project Management Plan
R R a. Project Charter
R R b. Project Team
R R c. Project Resources
R R d. Design Stages Used/Design Plan
R R e. Manufacturer Legal Information
R f. Organizational Structure
R R g. Responsibilities
R R h. Manufacturing and Packaging Processes
R i. Authorized Representative
R j. Notified Body
R k. Single Registration Number (SRN) (EUDAMED)
B2100X-03 Freedom to Operate Plan
R a. Marketing Plan
R b. History of Device
R c. Freedom to Operate Report
B2100X-04 Risk Management Plan
R R a. Risk Management Plan
R R b. Tracking and Trending of Incidents
R R c. Reportability of Incidents
R d. Benefit:Risk Analysis
R B2100X-05 Quality Operations/Manufacturing Plan
B2100X-06 Regulatory Plan
R R a. Post Market Surveillance Plan
R R b. Regulatory Plan/Strategy
R R c. Standards Applicability Report Draft
B2100X-07 Clinical Plan
a. Define Scope, generate CEP, and decide whether
R R
clinical investigation is required
R b. Clinical Evaluation Plan w Risk
R c. Clinical Follow-up Plan (All Classes)
R R B2100X-08 Software Development Plan
R R B2100X-09 Design Review
Phase 2 - Design Inputs
R R B2100X-10 Hazards Analysis Risk Assessment
R R B2100X-11 Design Risk Analysis
B2100X-12 Essential Requirements Inputs
R R a. Technical Inputs, VOC, Human Factors, Design, UR
R b. GSPR, Essential Requirements
B2100X-13 General
R R a. General Device Information
R R b. Intended Use (Purpose, User, Patient, etc.)
R c. Basic-UDI (UDI-DI)
R R d. Patient Population and Medical Conditions
R R e. Principles of Operation
(Interoperability/Compatibility/Usability)
R R f. Device Declaration
R R g. Risk Classification and Justification
R h. Novel Features
i. Lifetime of the Device Assessment, Obsolescence Plan,
R R
Lifespan Manual
R R j. Accessories
R R k. List of Configurations/Variants
R l. Key Functional Elements
R R m. Raw Materials
R R n. Software
R R o. Overview of previous generations
R R p. Product Equivalence
R B2100X-14 Traceability Matrix
R R B2100X-15 Design Review
Phase 3 - Design Outputs
R R B2100X-16 Hazards Mitigation
B2100X-17 Design Risk Mitigation
R R a. Biological safety risk assessment & mitigation
R R b. Design Risks Mitigation
B2100X-18 Essential Requirements Outputs
R R a. VoC Outputs
R R b. Human Factor Outputs
R R c. Design Outputs Summary Reports
R R d. Test Plans and Reports
e. Parts Specifications
B2100X-19 Product Drawings/Labeling Initiated
R R a. Device Labels
R R b. Packaging Labels
R R c. IFUs Draft
R R d. Promotional Materials (incl. Ordering Info)
R R B2100X-20 BOM Initiated
R R B2100X-21 dFMEA Initiated
R R B2100X-22 Engineering Tolerances Analysis
R R B2100X-23 Assembly Guidance
R R B2100X-24 Components/Materials To Be Outsourced
R B2100X-25 Engineering Assessment Plan
B2100X-26 Design Verification Plans
R R a. Hardware Design Verification Plan
R R b. Software Design Verification Plan
R R c. Process Design Verification Plan
R R d. Inspections Verification Plan
R R e. Test Methods Verification Plan
B2100X-14 Trace Matrix Updated
R R B2100X-27 Design Review - Product Specs
Phase 4 - Design Verification
R R B2100X-28 Vendor Analysis/Qualification
R R B2100X-29 pFMEA Start
R R B2100X-30 IMTE Development/Listing
R R B2100X-31 Components Specs
R R B2100X-32 In-House Component Development
R R B2100X-33 Production Equipment Development
R R B2100X-34 Packaging Equipment Development
R R B2100X-35 Tooling Qualifications
R R B2100X-36 Test Method Characterizations
B2100X-37 Process Development (DMR)
R R a. DHRs (Batch Records, Work orders, etc.)
R R b. Manufacturing Documents (SOPs, WIs, Forms, BOMs)
R R c. Final Inspections Used for Product(s)
R R d. Device Master Records
R R e. Software Programming Records
R R B2100X-38 IMTE Calibrations
B2100X-39 Outsourced Components Verification
R a. Usability Engineering File Completed
R R b. Stability Studies including Shelf Life
R R c. Sterilization Testing
R R d. Packaging/Transportation Testing
R R e. Functional/Chemical Testing
R R f. Approved Supplier's List
R R g. Supplier/Vendor Qualifications
R R h. Supplier/Vendor Agreements
R i. External Supplier CMR Assessments
j. Supplier Production Process Approval (SPPA) &
R
Production Part Approval Process (PPAP)
R R k. Process Flowcharts
R R l. Mfg/Pkg Specifications/Drawings Completed (SMS)
R R m. Supplier Quality Documentation
R n. CMRs in Contact Materials Confirmed/Rationalized
R R o. Complete Part Number Listing/ASL
R R p. Product Specifications
B2100X-40 In-House Components Verification
R a. Usability Engineering File Completed
R b. Stability Studies including Shelf Life
R c. Sterilization Testing
R R d. Packaging/Transportation Testing
R e. Functional Chemical Testing
R R f. Process Flowcharts
R R g. Mfg/Pkg Specifications/Drawings Completed (SMS)
R R h. CMRs in Contact Materials Confirmed/Rationalized
R R i. Complete Part Number Listing/ASL & PPAP
R R B2100X-41 Production Equipment Verification
B2100X-42 Pilot Build/Document Submissions
R a. Pilot Build(s)
R R b. Build Test Samples, Prelim simulated use testing
R R B2100X-43 Packaging Equipment Verification
R B2100X-29 pFMEA Complete/Verified
R B2100X-44 Process/Product Design Verification
R B2100X-45 Product Specs Verification
R R a. BOM Specifications Completed
R R b. Manufacturing Specs Completed
R R c. Packaging Specs Completed
R d. Software Specs Completed/Report
R B2100X-46 Drawings/Labels/Manuals Finalized
R R a. Labels Finalized (Labels, Flyers, Presentations, etc.)
R R b. Label Translations Completed
R R c. Drawings/Artwork Finalized
R R d. Operators Manual Finalized
R R e. Service Manual Finalized
R R f. Equipment Installation
R R B2100X-47 Risk Management Report
R R B2100X-48 Master Validation Plan
R B2100X-14 Trace Matrix Updated
R R B2100X-49 Design Review/Freeze
Phase 5 - Design Validation
R R B2100X-50 External Component Process Validation
R R B2100X-51 IMTE Test Method Validation
R B2100X-52 Compendial Validation
R R B2100X-53 Validation Product Builds (PQ)
B2100X-54 Quality Final Report
R R a. Sterilization Report and Procedures
R R b. Packaging, Transportation Testing Report
R R c. Cleaning Report and Procedures
R R d. Biocompatibility Report
R R e. Biomechanical/Functional/Chemical Testing Report
f. Compatibility Validation/Adoption Report
R R g. Electr Safety and Electromag Compatibility Report
R R h. VnV Memo of Equivalence
R R i. Biological Safety Risk Report
R R j. Reg Strategy, Eng Drawings sent to trade compliances
R R k. IMTE in place and calibrated
R l. EU MDR GSPR DD2888 Complete
R R m. SW VnV Report
R R n. Reprocessing Summary/Report/Validation
R R o. Quality Controls Used
R R p. Validations Completed
R q. Monitoring Summary
R R r. List of Mfg Sites
R R s. Final Inspections Used for Product(s)
t. Risk Management File (Plan, Hazards Assessment, Risk
R R
Control, Report & Solutions Adopted)
R R u. IFU Final
R R v. Device Master Record Index
R R w. Product Training for Sales, Customer Service, etc.
x. ERP System Elements Established
B2100X-55 Regulatory Final Report
R R a. Post-Market Surveillance Report (Class I)
R R b. Periodic Safety Update Report (Class IIa, IIb, III)
R R c. Relevant Regulatory Submissions/Approvals
R R d. Standards Applicability Report FINAL
R e. IP Review Complete
B2100X-56 Clinical Final Report
R a. Pre-Clinical/Clinical Data Evaluation Report
R b. Post-Market Clinical Follow-up Report
R R B2100X-57 Design Review/Release, Project Closure Report
Phase 6 - Project Transfer to Mfg
R R B2100X-58 Process/Product Transfer Plan
R R B2100X-59 Requalification/Revalidation Plan
R R B2100X-60 Manufacturing Transfer Report
B2100X-61 Project Closure Report
R a. Product Pricing Established
R b. Alpha Launch Plan complete
R c. EU QMS Certificate
R d. EU Techn Doc Assessment Certificate
R R e. Tech File/DHF Compiled
R f. EU Declaration of Conformity (DoC)
B2100X-62 Manufacturing Documentation (SOPs, WIs, etc.)
R R a. Standard Operating Procedures
R R b. Work Instructions
R R c. Forms
R R d. Tooling
R R e. Manufacturing Documentation Review Complete
R R f. Training (All support personnel)
B2100X-63 Packaging
R R a. Standard Operating Procedures
R R b. Final Artwork
R R B2100X-64 Phase 6 - Transfer Design to Manufacturing Review
Phase 7 - Project Transfer
R R B2100X-65 Process/Product Transfer Plan
R R B2100X-66 Requalification/Revalidation Plan
R R B2100X-67 Manufacturing Transfer Report
R B2100X-68 Project Closure Report
R B2100X-69 Regulatory Communications
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SOURCE DOCUMENT
REMEDIATION
Little remediation necessary, unresolved items are usually nonsubstantive
Gaps may be resolved with combination of rationale and remediation
Remediation mandatory: CAPAs, revalidations, redesign, generating documentation needed
RISK # % COMPL
#DIV/0! #DIV/0!
3
#DIV/0!
#DIV/0!
KEY:
1-3
3.1-7
7.1+
# QUESTION/ISSUE/COMMENT
1 Sample size determination - controlled/released document?
2 BSR-ENG-010, why Cpk over Ppk?
3 BSR-ENG-010, from what source is n=30 a good sample size?
4 BSR-ENG-010, definition of criticality (separate from risk)?
5 Storage conditions validated, but what about "in use conditions"?
Disinfection and cleaning console: what would happen is a person used a
6
solution NOT recommended by IFU?
Reuse of disposable sheath: how many times can the disposable sections be
7
sterilized/cleaned before degradation?
8 MDD Class 2B, what about MDR classification?
9 Design Control docs all over the place. Need better method to organize.
10 Supplier CAPA form all text, no way to easily extrapolate data.
11 QS0020.03 Quality Plan, aligned with 14971:2016. Plan to update to 2019?
12 SP0002, Design Controls uses FM0034 to document risks with AEGEA.
PD0026, Human Factors and Usability Engineering Plan, Table 1, Tasks and
13
Deliverables shows Phase Gate approach but light at best.
RA0026_03, Risk Mfg Plan & Report: policy states "to conduct yearly post
14 production risk mgt reviews as part of Mgt Review and Annual Product
Review." Were these done?
RA0026_03, Risk Mfg Plan & Report: policy states "monitor controls and risk
15 mitigations for effectiverness." Were these monitorings performed and
documented?
RA0026_03, Section 8.1.1.1.1, controller SW determined to be a "major level
16
of concern." Is SW documentation detailed enough?
17 RA0026_03, look at RA0027, Clinical Use Risk Analysis
RA0028, Systems Hazard ID, foreseeable misuse to see if all concerns were
18
addressed.
19 SP0047, dFMEA - review for completeness in MasterControl
PD0026 (Phase Gate) and RA0026_03 (Risk Mgt Plan) - check to see if they are
20
aligned.

Forms used do not usually lend themselves to pulling data. All forms expect
written statements from which data is not easily divined. Shouild be check
21
boxes and a way to pull data onto a spreadsheet for tracking and trending.
(Exception: FM0100-15.04 very good for pulling data. Emulate this.

QS0006_18, Quality objectives:

22 6.1.1 - what does this mean?
7.2.5.2 - Why not use yes/no?
 QS0006_18, Quality Objectives, Table 1:
1. No overdue NCMRs? What does overdue mean? What SOP?
2. No inservice? Does this mean no issues with equipment between regularly-
scheduled maintenance/calibration? What about MTBS?
23
3. IQC Yield of Components - good. What SOP deals with NC components from
supplier? How is yield calculated?
4. Mfg yields >/= 85%. How is yield calculated? Is this saying that 15% of units
that don't work going out to the field for use?

QS0006_18, Quality Objectives, QMS: Training - 100% on time training

completion not a real KPI. Training objective should be a result of reduced
24
NCs due to poor training, lack of understanding training, enforcement, mgt
directions, etc.

QS0006_18, Quality Objectives, QMS: Overdue CAPAs - all kinds of issues with
this direction. Due dates for CAPAs are arbitrary and set by company as to
25 "norms" for closing CAPAs. Only problem with overdue is if the CAPA is not
actively being worked on or pushed out for poor reasons. Extensions should
be eliminated altogether. Needs a serious discussion by Exec Mgt about this.

QS0006_18, Quality Objectives, Commercialization: 90% of complaint

26 investigations completed within 30 days (good). MDR reports filed on time
(good).

QS0006_18, Quality Objectives, Table 2:

27 3. Complaint rate per sales. Huh? Why would you care about complaint rates
when it is CAPAs that result from complaints that is the real concern.

QS0025.01: Clean Environment Room (CER) - confusing acronym since it is

also the same as Clinical Evaluation Report. CME (Controlled Manufacturing
28
Environment) is better.
7. Must meet requirements of Class 8, but not called out as Class 8?
29 QS0025.01: PR0379-P, PR0380-P - protocols for CER, review
30 QS0025.01: PR0381-P, PR0382-P - protocols for CDA
31 QS0025.01: SP0122 - Env. Monitoring Menlo Park, review
32 PD0027, PD0028_03 - SW Development Plan, review
33 PS0040 - SRS, review
8.1.1, 13485:2012 - What plans does company have to ensure aligned with
34
13485:2016?
PAR doc says end of life 1200 procedures (not sure where). BSR-ENG-003
35
corporate doc says 15 years. Needs reconciliation or alignment.
Problem with the way the documents are stored is that DHF documents are
mixed in with Clinical, QMS, QC, R&D, Metrology, Purchasing, and Training.
36
There is no distinction between these documents so a call has to be made as
to which are truly Technical File documents from not.
 FM0010_08 CAPA Form.pdf is WAYYYY to light for a CAPA program. No Pre-
37
CAPA inputs or escalation criteria, per this form.
BSR-ENG-001 - Sec. 3.1, 3.2, 3.3 don't make sense. Are these supposed to be
38 ALL the common documents that will be in a Technical File across facilities,
and then more specific documents in the Technical File per site?
BSR-ENG-001 - Sec. 8.3 Concept Creation: I don't understand the documents
39 that are supposed to be developed during this concept phase. The docs listed
are for much later on in the development of the product.

BSR-ENG-001 - Sec. 8.4.3: says design is "frozen" after this section, but there's
no way to freeze at this stage since so much still has to be tested and revised.
40
There is a lot of iteration in this stage from VnV stage. There are also design
changes to account to mitigations.

BSR-ENG-001: This document and explanation just feels like a design is being
"rushed." There are steps happening far too early in the process and therein
open to design flaws without going through the proper stages. It's a good
41
start for a small company that doesn't make very sophisticated equipment;
however, more sophisticated equipment need to walk through a more
granular PGP (product generation process).

BSR-ENG-001 - Sec. 8.6: During Launch Phase, personnel are supposed to

develop a Post Market Surveillance Plan during this last phase. This is
42 something that is supposed to be developed in the FIRST phase, along with
Post Market Clinical Followup Plans, Regulatory Plans, Manufacturing Plans,
Supplier Quality Plans, etc.

BSR-ENG-001: No offense, but this is NPD Lite. Time for a serious upgrade to
43
be a proper corporate document.
FormENG-426: not sure what to do about this. The phases clearly have a
jumbled up pile of various requirements that aren't in the proper order of
44
logical operations (refer to DHF List for example) Neither FormENG-426 nor
BSR-ENG-001 are aligned properly.
45
46
47
48
49
50
ANSWERS