SBS - The Best Value in QMS software

Class VI certification on seals, o-ring and plastic for a WFI system

ifserav

Involved In Discussions
#1
Hi everibody
Could you please tell me if it is necessary to get Class VI certificates of all the seals and o-ring on a WFI system?
What would be the better practice?
Thanks in advance

Sergio Avila
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
K MDR Class 1 Self Certification - Competent Authority or Notified Body? EU Medical Device Regulations 6
P ISO Class 8 particle count (annual certification vs monitoring) ISO 13485:2016 - Medical Device Quality Management Systems 4
M CE self-certification for Class I device (face mask) EU Medical Device Regulations 9
K EU MDD Class I Device market access / certification after 26th May 2020 EU Medical Device Regulations 9
D Notified body - CE Certification Class 2a Products in India CE Marking (Conformité Européene) / CB Scheme 4
B ISO 13485 certification advantages when I certify a Class 2a medical device CE Marking (Conformité Européene) / CB Scheme 12
K ISO 13485:2016 Self Certification for Class I (annex 9) Stand-Alone Software? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Is ANVISA site certification not required for Class I and II devices ? Other Medical Device Regulations World-Wide 1
Q Class I Technical File reviewed during ISO 13485 Certification Audit by NB CE Marking (Conformité Européene) / CB Scheme 10
A How much effort is needed for Certification of Class II Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 9
T Packaging Subcontractor Certification - Class I and Class II Medical Devices Supplier Quality Assurance and other Supplier Issues 2
S Is using Annex V of 93/42/EEC for CE Certification incorrect for a Class IIb Device? EU Medical Device Regulations 7
L Canadian Certification Required for a USA-Based Class I Medical Device? ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 Certification - Class II product - Fluoride-free toothpaste - Records ISO 13485:2016 - Medical Device Quality Management Systems 1
M QS9000 vs. Class A (lean) Manufacturing certification - What are the differences? Lean in Manufacturing and Service Industries 3
L "Shelf-Life" Class I Non-Sterile Products Expiration Date? CE Marking (Conformité Européene) / CB Scheme 2
S Stability sampling for Class 1 medical devices ISO 13485:2016 - Medical Device Quality Management Systems 1
T Including a class 1 camera in the 510k application of class 2 therapeutic technology? US Food and Drug Administration (FDA) 18
S Class I Equipment with mobile power inverter IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
shimonv Can you submit a traditional application for a class I device? Other US Medical Device Regulations 7
D Faxback form versus amendment License for Class II Canada Medical Device Regulations 1
K Ground Bond Test for Class I Medical Electrical Equipment - calibration problems IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J The necessity and benefit of ISO13485:2016 for a manufacturer of class I devices ISO 13485:2016 - Medical Device Quality Management Systems 3
L Class II (Double Insulated) Power Supply with Output Tied to Earth: FE or PE? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S IPC-A-610 Class 3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S Class 1 and 2 changes in CM standards (aerospace industry) Federal Aviation Administration (FAA) Standards and Requirements 0
S Class 1 vs Class 2 changes Federal Aviation Administration (FAA) Standards and Requirements 0
Fjalar Spare parts for discontinued MDD compliant class I medical device EU Medical Device Regulations 4
Y MDR requirements for Class I accessories EU Medical Device Regulations 2
J EU Declaration of Conformity for Class I EU Medical Device Regulations 3
H Class II a vs "software safety class A" IEC 62304 - Medical Device Software Life Cycle Processes 3
K Classification Rationale for class 1 EU Medical Device Regulations 3
N Class I accessories covered by EC certificate EU Medical Device Regulations 0
L Change Notification Requirements for class 1 devices Medical Device and FDA Regulations and Standards News 1
M Issues with leakage current testing for a CLASS II device since no PE and FE is present IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
J Med Device Class for a Service Organization ISO 13485:2016 - Medical Device Quality Management Systems 2
shimonv Clinical evaluation report for class I device EU Medical Device Regulations 3
D Control Number for Class III and IV devices Canada Medical Device Regulations 1
M Class II type machine , and its compliance with 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 14
K Technical file for MHRA - looking for assistance with self declaration Class I device CE Marking (Conformité Européene) / CB Scheme 8
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
J Instructions for use for Class I devices under MDR EU Medical Device Regulations 1
D Electrical Medical Devices class I EU Medical Device Regulations 0
K Interesting Discussion "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
L Class IIb devices marked EC according to the 93/42/CE - Portugal CE Marking (Conformité Européene) / CB Scheme 3
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
J Reusable surgical Instrument is under class IIa? EU Medical Device Regulations 4
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2

Similar threads

Top Bottom