AMS RoHS Regulatory Project Plan Presentation_April 2014
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Regulatory Project Plan Regulatory Overview – RoHS2 Regulatory Pathway – RoHS2 Addendum to Technical File(s) – Technical Documentation Assessment – Deliverables and Discussion – Supporting Documentation – F-0944, Rev. 6: Regulatory Project Plan (signed 27 Mar 2014) – D014273: Top-Level MVP – D013433: Environmental Compliance Assurance System – D022100: Manufacturing Plan 1 ©2012 American Medical Systems, Inc. All rights reserved. ©2013 American Medical Systems, Inc. All rights reserved.
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Transcript of AMS RoHS Regulatory Project Plan Presentation_April 2014
Regulatory Project Plan
Regulatory Overview
– RoHS2 Regulatory Pathway
– RoHS2 Addendum to Technical File(s)
– Technical Documentation Assessment
– Deliverables and Discussion
– Supporting Documentation
– F-0944, Rev. 6: Regulatory Project Plan (signed 27 Mar 2014)
– D014273: Top-Level MVP
– D013433: Environmental Compliance Assurance System
– D022100: Manufacturing Plan
1 ©2012 American Medical Systems, Inc. All rights reserved. ©2013 American Medical Systems, Inc. All rights reserved.
RoHS2 Regulatory Pathway
Complete XP System
Level V&V
Test Reports
Draft “RoHS2
Addendum” to TF per
EN50581
TUV Agency Test
Protocols and Reports
Complete “RoHS2
Addendum” after final
XPS System BOM
Released
Link ERC to V&V
Test Reports
Complete ERC Internal
Review with R&D/QA
per RA 124
RA sign New Declaration
of Conformity
TUV
Agency Testing
Complete RA Internal
Review of Technical
Files and Signature
Ready
XP System Test
Protocols and Reports
XP System Testing:
Bench, Shock & Vibe
RoHS-Compliant
XPS System
placed on EU Market
(7/22/14) Notified Body Audit
EU Rep Address
2 ©2013 American Medical Systems, Inc. All rights reserved.
Technical Files identified as “In-Scope” for RoHS
Compliance:
• GreenLight XPS Laser System TF
• GreenLight Fiber Assemblies (MoXY, HPS, PV) TF
• SureFlex Fibers TF
• Endo, Accustat Fibers TF
RoHS2 Addendum to Technical Files
– IAW EN 50581:2012 (Sec 4.3), each Technical File will be revised
(“RoHS2 Addendum”), to include the following section summaries for:
– Process Description
– List of Harmonized Standards
– Supplier Qualification Process
– Risk Assessment (supplier and material)
– Compliance Documentation
– Supplier Declarations
– Material Declarations
– Analytical Test Reports
3
Technical Documentation Assessment
– IAW EN 50581:2012 (Sec 4.3.1), the Manufacturer shall undertake the
following four tasks:
– Determine the information needed (4.3.2);
– Collect the information (4.3.3);
– Evaluate the information with regard to its quality and
trustworthiness and decide whether to include it in the technical
documentation (4.3.4); and
– Ensure that the technical documentation remains valid (4.3.5)
4
Process to Create Technical Documentation
©2013 American Medical Systems, Inc. All rights reserved. 5
Supplier & Material
Assessment
Evaluation of Quality
and Trustworthiness
Supplier
Declarations
Material
Declarations
Analytical Test
Results
Documents for materials, parts, and/or sub-assemblies
AN
D/O
R
AN
D/O
R
List of Harmonized
Standards or
Technical Specs
Information Showing
Relationship Between
Documents
General Description
of Product
Documents for
Materials
Content of Technical Documentation
4.3.2
4.3.3
4.3.4
Regulatory Deliverables and Discussion
– Technical File Deliverables Include:
– ERC Review and Approval per RA124
– Signed Declaration(s) of Conformity
– Perform periodic review of Technical File(s) documentation to ensure
that they are still valid; and
– Ensure that the Technical File(s) documentation reflects any changes
to materials, parts or sub-assemblies.
©2013 American Medical Systems, Inc. All rights reserved. 6
Regulatory Deliverables and Discussion
– Engineering Change Order (ECO) Review:
– Each RoHS-related ECO is individually assessed for impact on product
safety and effectiveness, to complete regulatory attributes, and further
regulatory recommendation or action (as appropriate)
– A preliminary regulatory assessment per RA102 determines that this
change will be referenced in a “RoHS2 Addendum” to Technical File
documentation (upon final System-Level BOM release to production)
without Notified Body submission and/or pre-approval.
– Medical Devices shall comply with RoHS2 provisions on the restriction of
hazardous substances and for continued CE Marking, when placed on the
EU market for the first time as of 22 July 2014.
©2013 American Medical Systems, Inc. All rights reserved. 7
Regulatory Change Order Review
0
50
100
150
200
250
300
350
Approval Released Initiate Rejected
29
78
133
58
213
116
19 31
262
87
8
99
312
99
38
Sep-13
Oct-13
Nov-13
Dec-13
Jan-14
Feb-14
Mar-14
©2013 American Medical Systems, Inc. All rights reserved. 8
Simple Agile PLM Workflow Search on ECOs:
• “RoHS” in Description of Change
• “RoHS” in Justification of Change
• May 2013 to-date
• Across all Product Lines
