Change id number: Process Change Worksheet

Print Name: ______________ Employee ID#: Signature: _ Date: ___

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Print Name: ______________ Employee ID#: Signature: _ Date: ___

Function: Business Unit: Other ____________

Design Reliability Quality Matls.Eng Mfg Eng CRDM Diabetes Neuromodulation Physio Control Cardiovascular

Surgical Technologies Spinal and Biologics

3. reliability/Design/or designee (Does not apply for spinal BU)

(Reliability Checklist)This section is to be signed by a BU representing this function

Yes	No	(To be completed by ONE of the following: Design/Quality/Reliability/ Matls. Eng. or designate)
		Requires bench, animal or clinical tests? Related Report(s): (If applicable) __________________________________
		Any change to materials, or manufacturing processes for materials used in the drug pathway (contacts drug) of the device?
		Requires biomatrix update? Related Report: (If applicable) ________________________________________
		Is any new or increased risks added to the device as a result of the change(s)? Related Report(s): (If applicable) ________________________________________
		Does the change impact the safety or performance of the device? Describe: _________________________________
		Does the change improve the product safety? Describe: _________________________________
		Requires technical file documentation update? Related Report(s): (If applicable) _________________________________
		Pumps/Catheters: Does change affect the drug fluid path? (For other than drug infusion components, answer is always “No”)

After completing this section, send to Business Unit Regulatory for completion of section 4.

Print Name: ____________________ Employee ID#: _ Signature: Date:

Function:
Design Reliability Quality Matls.Eng Mfg Eng

Business Unit: Other ____________
CRDM Diabetes Neuromodulation Physio Control

Cardiovascular Surgical Technologies Spinal and Biologics

4. Regulatory Affairs Assessment (Does not apply for spinal BU)

(To be completed by applicable BU Reg)

Worldwide Regulatory Summary

OUS Geography Assessment
Notification not required – implement change
Geographies notified and no action is required. Implement now Geographies:

Geographies notified and notification is required. Implement now Geographies:

Geographies notified and Prior Approval is required.

Do not Implement Geographies:

PCN Number, if applicable: __________________

United States Assessment (include rationale, where applicable)

1. Market Approved Products

Not applicable

Document to file

Annual report

Submit

2. Products Under Clinical

Not applicable

Document to file

Annual report

Submit

3. Products Under Development

Not applicable

Document to file/Pre-submission detail not needed

Annual report

Pre-submission include in submission

Under FDA review include in submission or amendment

Additional justification (i.e. Document to File justification) if applicable:

Print Name: ______________________________________ Employee ID#: _____________________ Signature: ___________________________ Date: ____________

Business Unit: Other ____________

CRDM Diabetes Neuromodulation Physio Control Cardiovascular Surgical Technologies Spinal and Biologics

A regulatory representative from each applicable business unit MUST approve this change as outlined in Business Unit section.

Spinal Business Unit Approval – GQ121 For Required Approval (Does not apply for Juncos and Villalba) (Does not apply for st)

(Approval Required)

Yes No

Regulatory Affairs
Design Quality

Sterilization Services

Strategic Procurement
Product Development
Concurrent Engineering
Packaging Engineering

(Approved)

Yes No

Name

___________________________

___________________________
___________________________
___________________________
___________________________
___________________________
___________________________
___________________________

Employee ID#

___________

___________
___________
___________
___________
___________
___________
___________

Signature

___________________________

___________________________
___________________________
___________________________
___________________________
___________________________
___________________________
___________________________

Date

_______

_______
_______
_______
_______
_______
_______
_______

Comments: (Attach additional sheets if necessary)

_____________________________________________________________________________________________________________________________

_____________________________________________________________________________________________________________________________
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6. Quality Assurance Approval

(To be completed by QA representative at mfg site for all changes)

Yes No

Device History Record Affected?

Approval sections (1 - 5, as required) complete?

Are required approving functions correct?

Signatures from all Business Units Affected?

Requires Testing?

Ref. Report(s): ______________________________

Yes N/A

Change to product verifiable?

Authorized design/ performance change?

Process change qualified?

ESD Impact Considered?

EHS Impact Considered?

Matrix/ FMEA PFMEA updated, if necessary?

New equipment/tools qualified?

Did you check that all red-lined documents versions established on the Affected Documents table on this form, match the version of the documents that were checked-in in Documentum?

Name: ______________________________ Employee ID#: _ Signature: _________ Date: _

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Change id number: Process Change Worksheet

Print Name: ____________________________ Employee ID#: ________________ Signature: ___________________________ Date: _______________

Print Name: ____________________________ Employee ID#: ________________ Signature: ___________________________ Date: _______________

3. reliability/Design/or designee (Does not apply for spinal BU)

Yes

No

Print Name: ________________________________ Employee ID#: _________________________ Signature: ________________________ Date: ____________

4. Regulatory Affairs Assessment (Does not apply for spinal BU)

Worldwide Regulatory Summary

United States Assessment (include rationale, where applicable)

A regulatory representative from each applicable business unit MUST approve this change as outlined in Business Unit section.

Spinal Business Unit Approval – GQ121 For Required Approval (Does not apply for Juncos and Villalba) (Does not apply for st)

Yes No

(Approved)

Yes No

Name

Employee ID#

Signature

Date

Comments: (Attach additional sheets if necessary)

6. Quality Assurance Approval

Yes No

Yes N/A

Name: ____________________________________ Employee ID#: ___________ Signature: ___________________________ Date: _______________

Print Name: ______________ Employee ID#: Signature: _ Date: ___

Print Name: ______________ Employee ID#: Signature: _ Date: ___

Print Name: ____________________ Employee ID#: _ Signature: Date:

Name: ______________________________ Employee ID#: _ Signature: _________ Date: _