Are EC type examinations still being conducted under MDR?

T

twanmul

Involved In Discussions
It also depends on whether CA against that annex is within the scope of the Notified Body's designation as to whether you can follow that procedure.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
G Trend analysis according to Article 88, MDR (EU), type of data point. EU Medical Device Regulations 1
M Type of bodily contact Other Medical Device Related Standards 1
R MSA Type 3 vs Type 1 Capability, Accuracy and Stability - Processes, Machines, etc. 12
X Separation of battery powered FB type applied part IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
R Separation and PE Requirements of a Type B Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
D Gage type and data base maintainence Using GAGEpack Software 2
Judy Abbott Type of contact- 10993-1:2018 Medical Device and FDA Regulations and Standards News 2
P Type of MSA study according to measurement equipment Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
CaliperJim Interval Type After First Use (AFU) General Measurement Device and Calibration Topics 6
R Repeatability Type 1 Gage and Gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
Z Why Control Limits are not the same depending on type of exclusion of data points Using Minitab Software 7
A IATF MSA study Type 1 General Measurement Device and Calibration Topics 7
M Type 1 Gage r study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
Nihls MSA Study Type 2 (special conditions ) IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
M Class II type machine , and its compliance with 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 14
W What is the difference between TYPE B and TYPE BF? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Nihls MSA Study Type 1 (CMM) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
D Separation of F-type applied part and remaining parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 13
M MSA Study Type 1 not capable. We are at the limit. And manufacturing wants to continue producing. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
cnbrosa Study Type 1 on a CMM using a measuring support Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
A Fabric roll inspection - What type of Control Chart to use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
A AMSQQP416E Class 2 type 2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S Medical watch Class II (AP Type CF) with USB connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
Johnnymo62 Non Aerospace topics - Anything for military trucks, trailers, Humvee type vehicles? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
N BF-type applied part MOPP vs secondary IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Marcel DS GOST-R (Type approval for Vehicles in Russia) Other ISO and International Standards and European Regulations 0
S Type 1 Gage R&R or something else? Reliability Analysis - Predictions, Testing and Standards 6
I Old Time Scatter diagrams for defect type and location- software Quality Tools, Improvement and Analysis 7
P Surgical masks ( type IIR) - Cleanroom Requirements EU Medical Device Regulations 3
W Insulation requirements of BF type infant skin temperature probe IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
N Infant radiant warmer - Heater Quartz Element type Other Medical Device Related Standards 0
N % Tolerance - Type 1 study on the gages, then a gage R&R (ANOVA) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
M Definitive answer on Type 1 vs Type 2 vs Type 3 Gage Study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
K Validation of new machine (second machine of the same type) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
F Operator Manual and Type B Uncertainty Measurement Uncertainty (MU) 3
B Minitab Type 1 Gage Study on True Position Question Measurement Uncertainty (MU) 1
M SI #7 8.4.2.1 Type and extent of control_supplemental IATF 16949 - Automotive Quality Systems Standard 3
B F-type applied part - Separation from ALL(?) other parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
A Gage type 1 study on CMM Capability, Accuracy and Stability - Processes, Machines, etc. 2
A IATF Sanctioned Interpretation No. 7 - Type and Extent of Control (supplemental) IATF 16949 - Automotive Quality Systems Standard 4
K F-TYPE APPLIED PART IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
I AS9100 8.4.2 Type and Extent of Control - External provider test reports Manufacturing and Related Processes 24
F Determining what type of scrap to include in my internal PPM calculation Quality Manager and Management Related Issues 5
R In this type of Legal Manufacturer-CMO arrangement, what happens to the DHR? ISO 13485:2016 - Medical Device Quality Management Systems 1
J AQL for Effectiveness Check - What AQL tiers to use on this type of sampling? Nonconformance and Corrective Action 9
T Type BF or CF (Direct conductive contact with the heart) IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
G MSA Type 1 - Cg and Cgk ranges Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
P IVDD - IFU related requirements - Type of information/statement expected EU Medical Device Regulations 1
B Documented process for type and extent of control IATF 16949 - Automotive Quality Systems Standard 6

Similar threads

Top Bottom