Did you use consultants for UDI?

Q

QA-Man

#1
There has been a consultant marketing blitz ever since UDI became a draft rule many years ago. I am curious if anyone has used consultants to get ready for UDI and I would like to know roughly how much you paid.

I know it is a broad question and there's a lot of possible variations. My ultimate goal is to get a ballpark figure of how much we (my company) saved by doing the work ourselves.
 
Elsmar Forum Sponsor
T

TroutBrook

#3
We did it ourselves. Thank heavens for all the good (free) info out there. FDA's UDI help desk was worse than useless.
 
Thread starter Similar threads Forum Replies Date
Q Where did my Alignment go wrong? MCOSMOS Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
N Yearly maintenance fee increased from$400 to $1500 USD - Did yours? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
L Did anyone hear business registration ontario? General Information Resources 1
Marc Quiz - Where did the idea of an assembly line come from? Coffee Break and Water Cooler Discussions 4
S Where did FDA 510(K) form 3654 go? Other US Medical Device Regulations 4
A Drawing Issue with Supplier - xb file did not match that of the pdf drawing Nonconformance and Corrective Action 4
Marc How did you "get" a full-time job? (A 2017 discussion) Career and Occupation Discussions 11
Marc When did you first use what we call E-Mail (aka email) today? Coffee Break and Water Cooler Discussions 17
B How did you grow your QMS in a Job Shop? Quality Manager and Management Related Issues 11
B Did UL 60601-1 change when the IEC 60601-1 standard changed to the 3rd edition? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T Test Report - Customer Signature - Customer did not witness test General Measurement Device and Calibration Topics 2
Marc Just for fun - How did you find the Elsmar Discussion Forum Forum News and General Information 9
GStough Is "Did Not Follow Procedures" Sufficient for RCA? Problem Solving, Root Cause Fault and Failure Analysis 30
Wes Bucey Did somebody drop the ball at Boeing? Quality Manager and Management Related Issues 38
Marc Did Stone Age cavemen talk to each other in symbols? Coffee Break and Water Cooler Discussions 7
A The auditor documented that we did not have control of Outsourced Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Hershal Travel! Where have you been of late? What did you see? What do you think? Travel - Hotels, Motels, Planes and Trains 15
T Did any of you use these sticks and rocks? Funny Stuff - Jokes and Humour 32
Q AS9100B Clause 7.5.1.5 - Where did it go in AS9100C? Servicing/Post Delivery Support AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Jim Wynne What did they do before Powerpoint? Funny Stuff - Jokes and Humour 3
Hershal How did you spend New Years? 2009 Coffee Break and Water Cooler Discussions 8
P New Year Goals and Resolutions - Did you keep your goals and resolutions in 2009? Coffee Break and Water Cooler Discussions 5
M Where did "breakpoint" analysis come from? AIAG MSA book Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
JoCam We did it!!! ISO 13485:2016 - Medical Device Quality Management Systems 7
L Where did the name Elsmar come from? Coffee Break and Water Cooler Discussions 17
N CQC (China Quality Certification) did not issue an Audit Report ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T Passed our registration audit - Well we did it!!!!!!! ISO 13485:2016 - Medical Device Quality Management Systems 16
P NC from TS16949 stage 2 audit - Internal Auditing - Auditor did not record evidence General Auditing Discussions 15
D Out of tolerance gauge blocks - How did these blocks go out of tolerance? General Measurement Device and Calibration Topics 21
Wes Bucey Laid off? Downsized? What did you learn? Career and Occupation Discussions 80
M TUV NCR 1 - Internal Audit did not audit the second shift Internal Auditing 26
R Looking for a link to a story - Because Nobody did it, the project didn't get done Coffee Break and Water Cooler Discussions 4
Ajit Basrur Certified Biomedical Auditor (ASQ) - What study materials did you use? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 6
Govind Did you know about ASQ Membership value Assessment Calculator? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 5
Govind ISO 10031- Did you know about this standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Wes Bucey Why did they need laptops in the first place? After Work and Weekend Discussion Topics 20
M Did anyone take the CSQE exam on saturday (6/3/2006) Professional Certifications and Degrees 6
C How did you survive your childhood? Coffee Break and Water Cooler Discussions 31
C Why did you not choose mechanical engineering? Interview Question Career and Occupation Discussions 6
C Career Change Question - Why did you choose Quality Engineer as starting job? Career and Occupation Discussions 3
SteelMaiden ISO 14001 certification yesterday afternoon - We did it! ISO 14001:2015 Specific Discussions 15
J Happy 2006 - How did you ring in the New Year Coffee Break and Water Cooler Discussions 16
P Why did ISO assign the number 16949 to TS 16949? Why not 123456 IATF 16949 - Automotive Quality Systems Standard 7
G Green Buildings And Leed - Did anyone go to "greenbuild" in Atlanta last week? Sustainability, Green Initiatives and Ecology 7
J TS 16949 8.5.2 Corrective Action - Auditor did not like the customer related form Nonconformance and Corrective Action 13
I We Did it!! Recommended for TS 16949 certification IATF 16949 - Automotive Quality Systems Standard 8
Marc Acronym DID - Acronym Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
Q SPC Terminoloy & Jargon: Cpk, Ppk etc.: How did it evolve? Capability, Accuracy and Stability - Processes, Machines, etc. 8
Wes Bucey ASQ (American Society for Quality) By-Laws Changes - How did you vote? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 15
Q Curiosity... The popularity of ISO 9001 if NA Automakers did not require it ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15

Similar threads

Top Bottom