Is getting a UDI Consultant a good idea?

J

Java23

Involved In Discussions
#1
#1
Hi - I am the lead for the UDI project. We need to be compliant by September 2016 for Class II devices (reprocessed/reusable).

I am doing my best to "teach myself" and have been thinking it would be best to use a consultant.

Has anyone used a consultant and if so, any ideas or suggestions?

I have looked online and am not finding a lot of options.

Thanks in Advance.:thanks:
 
Download Free White Paper
Elsmar Forum Sponsor
Y

yodon

Leader
Super Moderator
#2
#2
Re: UDI Consultants

I am not endorsing and I have no affiliation with them - I only sat through a webinar they provided. They seemed to have a reasonable understanding of the situation. I hope that's enough caveats. :) With those, you might try Reed Tech:

Haley Lentz
O: +1-215-441-6438 C: +1-215-756-7216
www.ReedTech.com - [email protected]
 
Ronen E

Ronen E

Problem Solver
Moderator
#4
#4
MF3009 said:
Hi - I am the lead for the UDI project. We need to be compliant by September 2016 for Class II devices (reprocessed/reusable).

I am doing my best to "teach myself" and have been thinking it would be best to use a consultant.

Has anyone used a consultant and if so, any ideas or suggestions?

I have looked online and am not finding a lot of options.

Thanks in Advance.:thanks:
Click to expand...
I am available if you're interested. Please send a PM.

Cheers,
Ronen.
 
J

Julie O

#5
#5
I normally think of a consultant as someone who has extensive experience in a particular area. The problem with UDI is that so far no one has extensive experience with it, because it's new. This is probably why you are not finding a lot of options.

Perhaps a more useful question under these circumstances might be "what type of experience should a UDI consultant have? You may find that, at this point in the history of UDI, you are as qualified to be a UDI consultant as anyone. If not, then you will at least know what you are looking for in a UDI consultant.

Also, are you aware that you posted this in the subforum for "Other Medical Device Regulations Worldwide," rather than "Other US Medical Device Regulations"? Since UDI is a US medical device regulation, I think you will find more UDI folks in the other sub-forum, where there has been quite a lot of chatter about the UDI.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
PQ Systems Getting the Most out of Master Gages Using GAGEpack Software 2
O How can fraud be avoided while getting an ISO certificate? ISO 17025 related Discussions 3
PQ Systems Getting Started with GAGEpack Using GAGEpack Software 0
R Getting harder to track the status of each one of the contracts Contract Review Process 0
Q Is it worth already getting UKCA? UK Medical Device Regulations 2
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5
M Getting started in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 31
C Difficulties getting RoHS/REACH for cheap parts RoHS, REACH, ELV, IMDS and Restricted Substances 1
NDesouza Getting Rid of Part Marking Errors Benchmarking 40
J Getting training either from ASQ or from SAI Global - ISO 9001 Lead Auditor training Training - Internal, External, Online and Distance Learning 1
blackholequasar Internal Auditing Inspiration - Getting volunteers to perform internal audits. Internal Auditing 22
L Getting Notice of Revision and Accessing Public Draft Copies of ISO Standards Service Industry Specific Topics 2
M (How To) Getting Data From Vision Machine To Reporting Software Misc. Quality Assurance and Business Systems Related Topics 0
Miner Getting logged off repeatedly Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 13
L Please help me with the process of getting ISO 9001 certified Quality Management System (QMS) Manuals 15
Z I need help with getting a CFS in China Manufacturing and Related Processes 2
M Getting into biotech QA from aerospace - Is it practical? Career and Occupation Discussions 2
S Business development and support - Getting business general liability insurance Career and Occupation Discussions 5
S ISO 17025 - Help in Getting accreditation- Where to start from ISO 17025 related Discussions 12
N Getting Married - How Will It Affect My Taxes? Coffee Break and Water Cooler Discussions 14
P Getting ready for Boeing's AC7130 requirement for suppliers using a CMM AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Ninja Getting eaten by Big Business - My company was bought by a huge multinational Coffee Break and Water Cooler Discussions 54
E SPC Production - Getting Cpk and Ppk Statistical Analysis Tools, Techniques and SPC 8
F Getting the audit procedure in my head (learning it) Quality Manager and Management Related Issues 3
Ajit Basrur Congratulations Steve Prevette on getting a Silver Star Covegratulations 11
Ronen E Congratulations Somashekar for getting the Silver Star Covegratulations 9
L PPAP Approval Woes - Getting signed PSW's back from Customers Supplier Quality Assurance and other Supplier Issues 15
Marc 50 Is the New 65: Older Americans Are Getting Booted from Their Jobs Career and Occupation Discussions 30
Rameshwar25 Getting values of k1, k2 and k3 for n=30, r=3 and k=3 Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
C Implementing ISO 9001 - Getting whole team buy-in? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
AnaMariaVR2 Getting Importers? Pulse About Food Safety Plans Food Safety - ISO 22000, HACCP (21 CFR 120) 3
M Getting your foot in the door? Entry level QA Career and Occupation Discussions 4
K Tips 'n Tricks for getting a Job in the early 21st Century Career and Occupation Discussions 1
Z Getting Charged for AS9104/1 Additional Audit Time General Auditing Discussions 6
Z Getting around GLP (Good Laboratory Practices) with FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A Getting Actionable Data from Returns Manufacturing and Related Processes 1
M Learning ISO 13485 - Getting a better understanding of the requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
J ISO13485 File-Index getting too large Document Control Systems, Procedures, Forms and Templates 2
M Putting Quality Management Together - Getting People to see Quality as a System Quality Manager and Management Related Issues 12
Randy Getting Red X 's in a box instead of pictures - I need some information.... After Work and Weekend Discussion Topics 10
A Getting Stuck Choosing a Sampling Plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
P Options for getting TV/Cable stations programming over the Internet After Work and Weekend Discussion Topics 6
G Getting Notifications of New Issues of Standards like AS9102 Quality Manager and Management Related Issues 3
S Getting Zero for GR&R Reproducibility? Using Minitab Software 5
M Trigonometric Calculation (V-Anvil Micrometer). I'm not getting it. General Measurement Device and Calibration Topics 6
D Getting into Quality Consulting Career and Occupation Discussions 7
D Promoting Company Wide Quality Drive - Getting Employee Buy In Quality Manager and Management Related Issues 15
G Internal Audit Planning - We are not getting the best out of our Internal Audits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Getting to the ASQ Exams at MD&M Chicago, 19 Sep 11 Professional Certifications and Degrees 5
B Getting the proper information from the supplier - Returning Nonconforming Material Nonconformance and Corrective Action 4

Similar threads

Top Bottom