Changing Notified Body - Anyone have stories to share

medic61

Involved In Discussions
#1
We are considering changing our notified body. Our current NB is not responding to our needs and waits until almost too late to shedule our audits.
If you have switched NB do you have "stories" to share about the changeover?
Thanks!
 
Elsmar Forum Sponsor

pkost

Trusted Information Resource
#2
Re: Changing Notified Body, anyone have stories to share

I can't give you a change over story, all I can say is that certainly in the UK, the NB's are under massive pressure from the competent authorities and EC to step up their game.

As far as I can tell, every one of them is under-resourced with leadtimes increasing massively.

I do not know your particular circumstance, however I would caution against jumping from the frying pan and into the flames
 
R

Reg Morrison

#4
Re: Changing Notified Body, anyone have stories to share

I can't give you a change over story, all I can say is that certainly in the UK, the NB's are under massive pressure from the competent authorities and EC to step up their game.

As far as I can tell, every one of them is under-resourced with leadtimes increasing massively.
Excellent comments. Unfortunately, some people are mistaken if they think that a change of Notified Body is as easy and seamless as the transfer of certification bodies. It is not. There is much more liability associated with the NB role (as exemplified in the PIP scandal) and Notified Bodies are becoming EVEN more bureaucratic slow careful in their operations, in order not to be caught in a multi billion lawsuit.

And, the worse part is, the problem is self afflicted. The Notified Bodies, many of them being certification bodies as well self impose low rates for their services, trying to be more cost-competitive, when, in reality, they should be increasing their rates, so they could attract real talent to work for them and do their part in assuring the safety of the products they notify.
 
Thread starter Similar threads Forum Replies Date
K Changing the Auditor within a Notified Body ISO 13485:2016 - Medical Device Quality Management Systems 4
M Impact of changing ISO 13485 registrar / notified body on Chinese SFDA approval ISO 13485:2016 - Medical Device Quality Management Systems 3
C Notified Body References and Reviews - Changing ISO 13485 Registrars EU Medical Device Regulations 8
D Changing a UK Notified Body - Anyone with any experience? ISO 13485:2016 - Medical Device Quality Management Systems 23
A Notified Bodies - Notifying Customers when Changing Registrars? EU Medical Device Regulations 9
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
R Impact of changing manufacturer post clinical investigation CE Marking (Conformité Européene) / CB Scheme 3
D Clothes changing in pharmaceutical factory Manufacturing and Related Processes 8
M Changing supplier of critical raw material (III class device) Other Medical Device and Orthopedic Related Topics 1
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T AS9100 - Changing PEARs target AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 41
C FDA on changing acceptance criteria re: analytical method validation US Food and Drug Administration (FDA) 1
V Statistical basis and justification while comparing / changing sampling plans Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
K Changing from Procedure based to Process based Competency Evaluations General Auditing Discussions 5
J Steps when changing material for class 1 medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Marc Email Addresses - Changing your email address Elsmar Xenforo Forum Software Instructions and Help 0
supadrai OEM Changing the name of the manufacturer - length of process? Is 1-3 months correct? Other Medical Device Regulations World-Wide 0
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
A IMDS - Changing the Locked Weight Value RoHS, REACH, ELV, IMDS and Restricted Substances 1
D Changing Templates Approval Field Document Control Systems, Procedures, Forms and Templates 5
P Romer Arm - Profile of a Surface Changing General Measurement Device and Calibration Topics 4
D Changing software classification via software - IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
L MINITAB 17 - Changing Data Using Minitab Software 3
S Process validation when changing location ISO 13485:2016 - Medical Device Quality Management Systems 10
Don Fardie CAPA vs. Risk Assessment - Changing a product material for better performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Changing Registrars Registrars and Notified Bodies 15
MDD_QNA Changing the Layout of Medical Device Label(s) CE Marking (Conformité Européene) / CB Scheme 3
S Keeping track of the changing Medical Device Standards Other Medical Device Related Standards 3
J Changing of our New Hire Orientation Training Records Training - Internal, External, Online and Distance Learning 12
A Changing a Form Template & Updating Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Is anyone changing their ISO 14001:2004 EMS Policy? ISO 14001:2015 Specific Discussions 8
Q Changing Terminology in ISO 9001:2015 - Documentation Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
V Changing Indication of Use for a Class IIa Medical Device EU Medical Device Regulations 2
B Changing out Thermocouple - Is new calibration required? General Measurement Device and Calibration Topics 1
F Rules to respect when changing from Certification Body ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
MDD_QNA Clinical data requirements - Changing a Class I Medical Device to Class II EU Medical Device Regulations 5
shimonv Changing the Label of a Medical Device product in the field Other US Medical Device Regulations 5
E Information required about changing an off shelf part 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Changing FMEA template to include Detection Ranking for the PFMEA FMEA and Control Plans 2
WCHorn Changing Sampling Accept Number to Zero, Arbitrarily AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
M Amending CFDA Registration for changing site of shipment China Medical Device Regulations 2
S Gage R&R on Potentially Changing Parts - Guidance Needed Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R Re-registration of medical device in Russia - "changing holder" Other Medical Device Regulations World-Wide 1
R Changing CE Mark on Documentation ISO 13485:2016 - Medical Device Quality Management Systems 2
B Process Capability - Changing Limits to Improve Cpk or find Root Causes? Capability, Accuracy and Stability - Processes, Machines, etc. 6
R Changing ISO 9001 Certification Scope Quality Manager and Management Related Issues 4
W Depth Gage Spindle moved when changing Contact Point Calibration and Metrology Software and Hardware 6
M Changing a Chinese Legal Agent China Medical Device Regulations 5
B Changing dimensional tolerances to approve rejected product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q How to handle customer request for changing specifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom