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New Post
Stijloor
24th January 2017 08:21 AM
Is a RJ45 LAN Connector worn on Body Medically Safe?
A Quick Bump! Can someone help with this question? Thank you very much! (76 views, 1 replies)
New Post
Stijloor
24th January 2017 08:21 AM
IEC 60601-1 Tensile Load Safety Factor
A Quick Bump! Can someone help with this question? Thank you very much! (93 views, 1 replies)
New Post
Stijloor
24th January 2017 08:20 AM
New Post
Stijloor
24th January 2017 08:19 AM
ARP 1820 Surface Contamination Testing
A Quick Bump! Can someone help with this question? Thank you very much! (184 views, 1 replies)
New Post
Stijloor
24th January 2017 08:18 AM
IEC 62366-1:2015 Usability Verification / Validation Plan example wanted
A Quick Bump! Can someone help with this question? Thank you very much! (114 views, 1 replies)
New Post
Big Jim
24th January 2017 06:13 AM
Meeting ISO 9001:2015 Clause 7.1.6 Organizational Knowledge Requirements
This is new territory. No one has figured it our yet. (2,636 views, 26 replies)
New Post
Big Jim
24th January 2017 05:56 AM
Objectives and KPI's (Key Performance / Process Indicators) S 5.4.1 of ISO 9001
I believe there is no significant difference. (11,589 views, 29 replies)
New Thread
batman1056
24th January 2017 05:20 AM
Costs, benefits, and consequences of ISO 9001
I have been asked by management to undertake a review which considers the costs, benefits and consequences of having a recognised number of accredited set of management arrangements. Consider the... (61 views, 0 replies)
New Post
Ronen E
23rd January 2017 08:53 PM
Accelerated Service Life Test for Medical Devices
Hi, Simulated life testing protocols can only be determined after carefully considering the specifics of the product, its use environment and use patterns, and above all - its anticipated failure... (95 views, 1 replies)
New Post
Project Man
23rd January 2017 08:49 PM
How to Calculate OEE Indicator for a Workshop (15 Machines)
I have been studying up on OEE lately and I've found this to be one of the best resources (I am not affiliated with this site in any way). http://www.oee.com/calculating-oee.html (155 views, 2 replies)
New Post
Ronen E
23rd January 2017 08:43 PM
ISO 13485:2016 and 21 CFR Part 820 - Checklist sought
It's super-easy to get hold of such a checklist, and all other similar ones for that matter. The real question is whether one is willing to pay for the effort it takes to create it. (198 views, 2 replies)
New Post
Ronen E
23rd January 2017 08:19 PM
Electrical and Electromechanical Product CE Compliance with various Directives
Unfortunately there is no recurring theme across the 20-something CE marking directive regarding self-certification vs. 3rd party certification. The mechanics are detailed within each directive, so... (380 views, 15 replies)
New Post
Jen Kirley
23rd January 2017 07:50 PM
Life is Short
I am sorry. I lost my mother after she dealt with Alzheimer's for years and was caring for her at home. Even though one can feel a kind of relief about the end of the suffering one is never truly... (230 views, 5 replies)
New Post
Jen Kirley
23rd January 2017 07:40 PM
About NDT (Non-Destructive Testing) and ISO 17020
ISO 17020 is for organizations' management systems. Inspections would be done in accordance to industry specifications. Your organization would be set up to recognize what they are, ensure they are... (212 views, 4 replies)
New Post
try2makeit
23rd January 2017 04:32 PM
Calibration Status of Gauges for Training Only
Can you calibrate everything, and then mark the gages that are being used for training or field uses as such and have them at a different location then the ones used for work? Think that be a lot... (80 views, 1 replies)
New Post
DRAMMAN
23rd January 2017 03:58 PM
Anyone using a cloud based QMS software?
Yes. Also if anyone is using the QMS specific cloud applications such as Verse Solution, Master Control, etc. I am interested in hearing about your experiences. I am not a SW seller but would be a... (106 views, 2 replies)
New Post
Big Jim
23rd January 2017 02:53 PM
Interpreting AS9100 Clause 8.2.2 Internal Audit Requirements
It is always difficult to respond to a nonconformance that you don't fully understand or buy into. You are in an awkward spot because the true root cause here is management commitment, and you... (6,596 views, 27 replies)
New Post
Bev D
23rd January 2017 02:00 PM
Powder Weight Proportion Measurement Gage R&R
yes - it is part of the measurement system. (91 views, 3 replies)
New Post
chris1price
23rd January 2017 11:57 AM
Development Meeting with the FDA - Approval Pathway for a Combination Product
Hi, Shimonv makes some very good points. I would also make sure everyone is familiar with the recently released Final Rule on cGMPs and Combination Products so there are no surprises. ... (163 views, 3 replies)
New Post
chris1price
23rd January 2017 11:47 AM
ISO 13485 Certificate Scope modified by Notified Body
Hi, the contents of the scope are always a discussion with the notified body and I'm sure you can push back if you think its appropriate. "Servicing" is the term used in ISO13485 and so may be a... (155 views, 2 replies)

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