Change of Sterilization Vendors / Facility

K

katastic2908

#1
Please help,

I was hoping someone could help me because trying to search this stuff on the internet is so confusing and most of the time I just end up here anyway.

We are in the midst of qualifying a new sterilization facility, the one we currently use is closing down the location that we use so we are qualifying one of their other locations.

We are in the process of validating and dose mapping, can anyone tell me if I need to notify the FDA somehow? Also for EU, would this be something I would do on a Significant Change Notification to our NB? TIA
 
Last edited:
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

FDA - yes, you will need to have your records updated. How exactly depends on what kind of device it is and what was your initial clearance route.

EU/NB - you are only obliged to proactively notify the NB between audits if the change involves QMS or product-range changes, or the device initially went through the “design examination” route (See MDD Annex II s. 4) in the first place.

Please send me a PM if you’d like to provide detailed information and have me further look into this for you.

Cheers,
Ronen.
 
Thread starter Similar threads Forum Replies Date
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
H Change of a medical device sterilization dose - New 510(k) necessary? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Re-validation of EtO sterilization after change of tape Other Medical Device and Orthopedic Related Topics 1
G Sterilization Re-Validation after Manufacturer Change Qualification and Validation (including 21 CFR Part 11) 17
S Gamma Sterilization: Change in Bulk Density vs. Revalidation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S When to change the status of a GTIN from "Premarket" to "In Use" ? US Medical Device Regulations 0
Y Is there any EU Significant change guidance issued? EU Medical Device Regulations 5
B How to change hour format to text but not changing the number ? Excel .xls Spreadsheet Templates and Tools 1
N API Q1, Management of Change & Document Change Request Oil and Gas Industry Standards and Regulations 3
adir88 Substantial Change to QMS (Annex IX, Chapter I) EU Medical Device Regulations 0
A Eudamed actor registrations if you change AR for MDR product EU Medical Device Regulations 0
C Change Management Process ISO 14971 - Medical Device Risk Management 8
S ISO13485:2016 7.3.9 design and development change ISO 13485:2016 - Medical Device Quality Management Systems 3
N Change Control for processes & products Manufacturing and Related Processes 7
Q Change Control Numbering system Document Control Systems, Procedures, Forms and Templates 7
D Laboratories listed in the Declaration of Conformity change Canada Medical Device Regulations 1
M Change control on Tracking Sheet ISO 13485:2016 - Medical Device Quality Management Systems 11
D EU MDR - Change of device name (legacy device) EU Medical Device Regulations 17
L Change Log in (controlled) Forms? (ISO 9001:2015) Document Control Systems, Procedures, Forms and Templates 6
H Control of Change i.e. process and WI IATF 16949 - Automotive Quality Systems Standard 9
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
K Is implementing Electronic Signatures a Significant Change to the QMS? ISO 13485:2016 - Medical Device Quality Management Systems 10
A Management of change procedure for ISO 45001 Occupational Health & Safety Management Standards 5
N Cleanroom Classification Change Other Medical Device Related Standards 7
D Engineering Change order vs. Change Control ISO 13485:2016 - Medical Device Quality Management Systems 3
Watchcat Change Request Documents - What's Typical These Days? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
NDesouza Management of Change (MOC) Manufacturing and Related Processes 11
H Customer Specific Change in a SaaS SAMD IEC 62304 - Medical Device Software Life Cycle Processes 1
D GAMP CAT 5 Change Control Qualification and Validation (including 21 CFR Part 11) 9
lanley liao Questions regarding the change of critical suppliers and key personnel Oil and Gas Industry Standards and Regulations 5
I What revalidation is necessary if we change parts in a WFI loop ? Qualification and Validation (including 21 CFR Part 11) 1
Y Exporting data to the cloud is a "Significant Change"? EU Medical Device Regulations 5
A Design Change/ECO Related Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Reseller Request to Change UPC on Medical Device via Re-labeling Medical Device and FDA Regulations and Standards News 5
S Change management with FAA Federal Aviation Administration (FAA) Standards and Requirements 0
R Revalidation under VDmax25 following material change ISO 13485:2016 - Medical Device Quality Management Systems 2
D Change to labelling - does it require a new 510(k)? US Food and Drug Administration (FDA) 5
A How can we change a device trade name in 510(k) summary? US Food and Drug Administration (FDA) 0
L Change Notification Requirements for class 1 devices Medical Device and FDA Regulations and Standards News 1
R CB/Auditor Requiring a change in scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Ed Panek Notified Body Substantial Change MDD EU Medical Device Regulations 1
A Purchasing Controls on Change Management of Literature/Labeling ISO 13485:2016 - Medical Device Quality Management Systems 3
A For software change - New Channel of interoperability CE Marking (Conformité Européene) / CB Scheme 5
JoCam IEC 60601-1 and 60601-1-2 retest after PCBA change IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
R AS9102 FAI Change in Material / Process Supplier AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Time change via change of Time Zone Qualification and Validation (including 21 CFR Part 11) 3
T IEC 60601-1-8:2020 Is it necessary to change the alarm melody? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5

Similar threads

Top Bottom