Medical Device - fixture qualification and MSA

Watermelonsg

Starting to get Involved
#1
Hi all,
We are now qualifying a fixture which is to test the strength of the joint after welding. This is a destructive test.
My understanding is that after we define the function of the fixture, we will verify the fixture against the function, during which we are going to do some test, for which we will also perform MSA to analyze the variation from the fixture and operator as well as the variation of the part.
If basic functionality check pass and MSA result is acceptable, we will declare FQ is successfully done before releasing it to manufacturing.

Can someone share some insight if this is correct procedure for fixture qualification in medical industry?
Best if this is sufficient. if not, what else should we do.
If we are overdoing, what will be the best approach?

Thanks!
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
J Medical Device Manufacturing Manufacturing and Related Processes 3
M An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER) EU Medical Device Regulations 0
O Regarding design and development requirements for a medical device EU Medical Device Regulations 6
U Leakage test Standard for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E Tablet integrated into medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
Ed Panek Is this a medical device? US Medical Device Regulations 2
P Medical device testing lab/service standard Other Medical Device Related Standards 1
K Medical Device file and "Component" Manufacturers? Other Medical Device and Orthopedic Related Topics 6
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
C Statistics/sampling plan for medical device Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Non-medical device testing in the medical system IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Training in D&D for engineers with no medical device experience Design and Development of Products and Processes 8
M Software as Medical Device import activities for Chile and Mexico Other Medical Device Regulations World-Wide 0
M Medical Device Indications for Use Health Canada Canada Medical Device Regulations 6
J Average number of Nonconformances during internal quality audit for Medical Device Manufacturers Internal Auditing 3
D Exclusion 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 5
M Lifetime of medical device EU Medical Device Regulations 16
M UDI IVD Medical Device Class III US Food and Drug Administration (FDA) 1
E How to risk assess tooling? For a medical device and is it needed??? Manufacturing and Related Processes 2
P Definition of "Standalone" medical device Other Medical Device Regulations World-Wide 5
B Spare parts of medical device need CE mark? EU Medical Device Regulations 0
R EU MDR Article 22 applicability of medical device with components. EU Medical Device Regulations 4
M Medical Device AE Reporting SOP Medical Device and FDA Regulations and Standards News 0
M Class Exempt Medical Device Recall Question US Food and Drug Administration (FDA) 3
B Technical Documentation for a medical device accessory Medical Device and FDA Regulations and Standards News 6
S Assembling technical file for a medical device ISO 13485:2016 - Medical Device Quality Management Systems 1
K Class I Medical Device Registration EU Medical Device Regulations 11
B Telemedicine as a Medical Device EU Medical Device Regulations 4
S Definition of disease as per medical device defintion EU Medical Device Regulations 14
Q Class I Medical Device with measuring function (UK MDR 2002 / MDD) UK Medical Device Regulations 3
G No new regulations in Austria medical device register after 26th Mai, 2022 EU Medical Device Regulations 0
A What activities are included in the action of marketing you medical device in U.S.? Medical Device and FDA Regulations and Standards News 1
M CE marked medical device - do they need UKAS certified calibration provider ISO 17025 related Discussions 4
C Is there a list of products or classifications subject to medical device regulations in El Salvador? Other Medical Device Regulations World-Wide 0
R Class II Active Medical Device SYSTEMS and COMPONENTS Canada Medical Device Regulations 2
B Rework of a medical device EU regulations EU Medical Device Regulations 5
S Drawing Requirements for Catalog Items (Class II Medical Device) US Food and Drug Administration (FDA) 3
V ADDING NEW MEDICAL DEVICE / Product, WHEATHER THIS AFFECTS EXISTING ISO 13485 CERTIFICATION? ISO 13485:2016 - Medical Device Quality Management Systems 4
C Regulatory Affairs in a start-up medical device company Career and Occupation Discussions 1
somashekar Medical device file Vs Role undertaken by the organization ISO 13485:2016 - Medical Device Quality Management Systems 1
M Medical Device Label - Language EU Medical Device Regulations 2
D MDR: Active medical device or not? Medical Information Technology, Medical Software and Health Informatics 14
H Mapping QMS+business processes in a medical device with class I and IIa+b Process Maps, Process Mapping and Turtle Diagrams 3
Aliken Registration veterinary medical device (laser) requirements Medical Device and FDA Regulations and Standards News 2
T Classification Accessory Software medical device EU Medical Device Regulations 4
J CGMP Medical device slide deck Manufacturing and Related Processes 1
M Notification Requirements for Medical Device Raw Materials 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Madagascar medical device regulation Other Medical Device Regulations World-Wide 0
R Steam sterilizer medical device reclassification EU Medical Device Regulations 6

Similar threads

Top Bottom