MDR consultants - in search of recommendations for a consultant for MDR transition.

Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
Watchcat

Watchcat

Trusted Information Resource
#4
#4
A couple of questions for you:

1. Is the company currently a client of an MDR-designated NB? An NB that is seeking MDR designation? Or are is it going to have to find one?

2. Are you sure it needs help with the transition, or might it be at step 0, which is the step where you figure whether it will make any business sense to keep the product on the EU market post-MDR?
 
S

SMBIZZQA

Starting to get Involved
#5
#5
1. Yes, we currently have an NB, and already have certification and CE.
2. We definitely need to transition, however I currently don't have the resources to do all the necessary steps. Basically need someone to come in and review what we currently have in our tech files and do a gap analysis for us. I am a one party QA department.
 
Watchcat

Watchcat

Trusted Information Resource
#6
#6
That's good!

That was going to be my next question...what kind of assistance do you need. I'm going to contact you via PM, but I asked these questions here on the thread because I think anyone who might be available to help you will find it helpfu.
 
Watchcat

Watchcat

Trusted Information Resource
#7
#7
Oh! Something else I think others will find helpful to know:

What is the basis for the organization and contents of your current technical file? NB-MED 2.5.1? STED?
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#8
#8
If I may recommend myself, I do... I'd be glad to help.
I don't mind travelling, but I'm not sure it would be cost-effective in this case... I'm based in Australia. However, I'm very confident (based on experience) that the gap analysis and the vast majority of any required gap filling can be done remotely.
Please send me a PM if interested.
Cheers,
Ronen.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
T Choosing a Notified Body for MDR - SGS/BSI/DNV/DQS-MED Registrars and Notified Bodies 0
M Reworking MDD product w MDR labeling CE Marking (Conformité Européene) / CB Scheme 0
A MDR and Poland EU Medical Device Regulations 6
Ed Panek Invitation to the MDR Dance EU Medical Device Regulations 5
M EU MDR language-Translation requiremens CE Marking (Conformité Européene) / CB Scheme 8
I What are suitable indicators and threshold values in MDR/IVDR? Medical Device and FDA Regulations and Standards News 5
A Sell-off legacy devices MDR EU Medical Device Regulations 0
A Eudamed actor registrations if you change AR for MDR product EU Medical Device Regulations 0
Ed Panek Which choice of the following most closely matches the MDR compliance of your company? EU Medical Device Regulations 0
K Definition of SAE under MDR EU Medical Device Regulations 3
Q Harmonised Standards (EN ISO 13485 / EN ISO 14971) in MDR (2017/745/EU) ISO 13485:2016 - Medical Device Quality Management Systems 3
Ed Panek Clarity from EC on Importer/Distributor roles in MDR EU Medical Device Regulations 9
Pmarszal BS EN 20417:2021 - Implementation Timeline Aligned With MDR? Other ISO and International Standards and European Regulations 1
T Dental lab acrylics and MDR EU Medical Device Regulations 0
S Biggest issues when producing MDR compliant Technical Files / DD EU Medical Device Regulations 4
A Declaring Conformity with MDR Article 120(3) for an MDD Legacy Device EU Medical Device Regulations 1
D EU MDR - Change of device name (legacy device) EU Medical Device Regulations 4
J Technical Documentation as per MDR / subpoint 6.1 EU Medical Device Regulations 3
M EU MDR - Retrospective Study for expanding indications of a legacy device EU Medical Device Regulations 0
B MDR Technical Structure EU Medical Device Regulations 3
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
L Configurable UDI mdr EU Medical Device Regulations 0
O EU MDR labels EU Medical Device Regulations 1
S Summary of safety and clinical performance and Article 120(3) of the MDR EU Medical Device Regulations 4
M MD Class I transition period MDD to MDR - changes? EU Medical Device Regulations 1
C UDI for consumable/replacement components under the MDR EU Medical Device Regulations 2
E Article 17 MDR - (Re-)Processing EU Medical Device Regulations 0
H Article 22 MDR System EU Medical Device Regulations 16
L REACH compliance with MDR EU Medical Device Regulations 4
L EU MDR Ramifications for no expiration date on labeling EU Medical Device Regulations 1
R How to obtain OBL licence under Indian MDR, 2017 Other Medical Device Related Standards 2
F MDR – Article 120 – Transitional provisions EU Medical Device Regulations 8
H MDR Article 13(c) EU Medical Device Regulations 6
Ed Panek Auditor MDR (Presub audit) finding EU Medical Device Regulations 2
M Classification of Instruments under EU MDR EU Medical Device Regulations 1
M Procedure for vigilance system according to new MDR EU Medical Device Regulations 0
M Procedure for clinical evaluation according to new MDR EU Medical Device Regulations 11
R MEDDEV 2.12-1 rev 8 (Vigilance guidelines) still applicable with the MDR implementation? EU Medical Device Regulations 1
S Determining a device category according to the MDR EU Medical Device Regulations 3
A Transactions under MDR Medical Device and FDA Regulations and Standards News 3
H Has anyone undergone MDR FQA review yet? EU Medical Device Regulations 10
S UK MDR + EU MDR Declaration of Conformity UK Medical Device Regulations 2
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1
H MDD VS MDR 2002-218 UK Medical Device Regulations 6
Ed Panek MDR Liability Insurance EU Medical Device Regulations 1
S MDD to MDR - Tallow Derivatives Impact EU Medical Device Regulations 1
P Update on NBOG 2014-3 to address MDR/IVDR, or any plan to do that? EU Medical Device Regulations 0
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
S MDR GSPR Standards EU Medical Device Regulations 1
A MDR - Legacy Device Review Timeframe and Requirements EU Medical Device Regulations 3

Similar threads

Top Bottom