Changing supplier of critical raw material (III class device)

M

Marilyn

Registered
#1
#1
Hi,

We are manufacturing III class custom-made medical devices (no CE certificate). What quality activities are required if I change the supplier of critical raw material? The specification of the raw material stays the same as it is already accepted. So the raw material itself will not change.

I´m wondering, if I should perform the evaluation of this new supplier just according our normal procedure of "supplier evaluation"? Or is there something more I have to consider?
 
Last edited:
Elsmar Forum Sponsor
planB

planB

Trusted Information Resource
#2
#2
Marilyn,

presuming you have an established quality system, assess the impact of this change in terms of whether the V&V activities you performed on your device with existing supplier would be affected by this supply change. Your "normal" change control procedure should cover all aspects relevant for your device, including how to qualify new suppliers. Since you already had qualified the existing raw-material supplier successfully at some point in time, you would have an internal precedence of how to qualify an equivalent new supplier.

HTH,
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
E Changing Critical Supplier: What are the requirements Other US Medical Device Regulations 8
shimonv Updating Safety Test Report when changing component supplier IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Impact of changing manufacturer post clinical investigation CE Marking (Conformité Européene) / CB Scheme 3
D Clothes changing in pharmaceutical factory Manufacturing and Related Processes 8
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T AS9100 - Changing PEARs target AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 41
C FDA on changing acceptance criteria re: analytical method validation US Food and Drug Administration (FDA) 1
V Statistical basis and justification while comparing / changing sampling plans Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
K Changing from Procedure based to Process based Competency Evaluations General Auditing Discussions 5
J Steps when changing material for class 1 medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Marc Email Addresses - Changing your email address Elsmar Xenforo Forum Software Instructions and Help 0
supadrai OEM Changing the name of the manufacturer - length of process? Is 1-3 months correct? Other Medical Device Regulations World-Wide 0
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
A IMDS - Changing the Locked Weight Value RoHS, REACH, ELV, IMDS and Restricted Substances 1
D Changing Templates Approval Field Document Control Systems, Procedures, Forms and Templates 5
P Romer Arm - Profile of a Surface Changing General Measurement Device and Calibration Topics 4
D Changing software classification via software - IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
L MINITAB 17 - Changing Data Using Minitab Software 3
S Process validation when changing location ISO 13485:2016 - Medical Device Quality Management Systems 10
D CAPA vs. Risk Assessment - Changing a product material for better performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Changing Registrars Registrars and Notified Bodies 15
MDD_QNA Changing the Layout of Medical Device Label(s) CE Marking (Conformité Européene) / CB Scheme 3
S Keeping track of the changing Medical Device Standards Other Medical Device Related Standards 3
J Changing of our New Hire Orientation Training Records Training - Internal, External, Online and Distance Learning 12
A Changing a Form Template & Updating Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Is anyone changing their ISO 14001:2004 EMS Policy? ISO 14001:2015 Specific Discussions 8
Q Changing Terminology in ISO 9001:2015 - Documentation Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
V Changing Indication of Use for a Class IIa Medical Device EU Medical Device Regulations 2
B Changing out Thermocouple - Is new calibration required? General Measurement Device and Calibration Topics 1
F Rules to respect when changing from Certification Body ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
MDD_QNA Clinical data requirements - Changing a Class I Medical Device to Class II EU Medical Device Regulations 5
shimonv Changing the Label of a Medical Device product in the field Other US Medical Device Regulations 5
E Information required about changing an off shelf part 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Changing FMEA template to include Detection Ranking for the PFMEA FMEA and Control Plans 2
WCHorn Changing Sampling Accept Number to Zero, Arbitrarily AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 15
M Amending CFDA Registration for changing site of shipment China Medical Device Regulations 2
S Gage R&R on Potentially Changing Parts - Guidance Needed Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R Re-registration of medical device in Russia - "changing holder" Other Medical Device Regulations World-Wide 1
R Changing CE Mark on Documentation ISO 13485:2016 - Medical Device Quality Management Systems 2
K Changing the Auditor within a Notified Body ISO 13485:2016 - Medical Device Quality Management Systems 4
B Process Capability - Changing Limits to Improve Cpk or find Root Causes? Capability, Accuracy and Stability - Processes, Machines, etc. 6
M Changing Notified Body - Anyone have stories to share CE Marking (Conformité Européene) / CB Scheme 3
R Changing ISO 9001 Certification Scope Quality Manager and Management Related Issues 4
W Depth Gage Spindle moved when changing Contact Point Calibration and Metrology Software and Hardware 6
M Changing a Chinese Legal Agent China Medical Device Regulations 5
B Changing dimensional tolerances to approve rejected product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q How to handle customer request for changing specifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Change Control Requirements when changing Suppliers IATF 16949 - Automotive Quality Systems Standard 4
P Changing from contract manufactured to self manufactured 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Document Control - Changing Company Logo Document Control Systems, Procedures, Forms and Templates 10
Similar threads
Top Bottom