SBS - The best value in QMS software

Long time for NB to review to change the classification of one of our products!

S

SteveK

#1
#1
I sent a request to our NB to change the classification of one of our products from IIa to Im with the appropriate justification and information – for what is classed as a significant change under NB-MED/2.5.2/Rec5 (and now NBOG BPG 2014-3). I just received today an invoice for their review time (one hour in November 2014 and two hours this March). However I submitted the request 14 months ago! Can anyone beat this?

Steve
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
C

Charlotte Percy

#3
#3
Hi Steve,

Did you get the change approved? If so 3 hours would be considered a good price!
 
somashekar

somashekar

Staff member
Super Moderator
#4
#4
Our NB auditor during the April 2015 MDD surveillance, checked upon our technical file updations, and more particularly the Label changes if any. We were informed that any changes / updations made in the technical file would go through a review man hours cost that will depend upon the extent of changes / updations made. Luckily there were none and we did not bother to ask the rate for review man hours. I am still awaiting the final report, 40 days through...
 
S

SteveK

#5
#5
I've had no notification that the change has actually been approved - just assuming so due to the invoice. By the way we had our annual surveillance audit in November 2014 - still have not received the report (we have had the audit invoice though). Cannot remember if I mentioned this in another post, but the last TFs we were requested to submit; according to a NB issued schedule and post audit report request, was in 2013. According to this schedule two more TFs were due review in 2014. However, when I asked the NB when should I send these (since they need to have a reviewer booked in place) I was told I did not need to submit another TF until 2016! I thought it was a mandatory (MHRA?) requirement to submit annually. Anyway not complaining - cuts down on NB costs!

Steve
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
B Management Review Meetings too Long - How to Shorten and Improve Effectiveness Management Review Meetings and related Processes 7
C Packaging Long Parts Manufacturing and Related Processes 3
M Old Master Schedules - How Long to Keep? Document Control Systems, Procedures, Forms and Templates 4
W How long do you keep information about equipment no longer used? Document Control Systems, Procedures, Forms and Templates 2
S How long does it take to register a product with MHRA? UK Medical Device Regulations 4
Watchcat How long is this going to take? (UK & ventilators) Manufacturing and Related Processes 14
P Images of Product for Automated Process - How long to keep? US Food and Drug Administration (FDA) 2
D How long should we keep the spare parts available for our medical device, after we have stopped the production? ISO 13485:2016 - Medical Device Quality Management Systems 0
R How long to wait for Notified Body Response - Potentially significant change to a medical device CE Marking (Conformité Européene) / CB Scheme 6
1 How to measure straightness on a HEX Long Bar Manufacturing and Related Processes 7
A PFMEA - How long should the recommended actions remain in the recommended actions column? APQP and PPAP 3
M FDA News Statement from USFDA on steps to strengthen the long-term safety oversight of the Essure device Medical Device and FDA Regulations and Standards News 0
A Class I medical device and Category III PPE - Long length gloves EU Medical Device Regulations 5
T How long will ISO 9001:2015 Recertification Take? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q Tracking savings - Long term projects and the day to day decisions Preventive Action and Continuous Improvement 5
C How long is an OEM obligated to provide spare parts and repair EU Medical Device Regulations 2
S Record Retention - How long must a company keep the following records? Records and Data - Quality, Legal and Other Evidence 17
L Please help my division with quality [long] Service Industry Specific Topics 1
J How long should I have to correct an audit finding? VDA Standards - Germany's Automotive Standards 7
A How to systemically improve product quality in short-term and long-term basis? Preventive Action and Continuous Improvement 1
B Short term vs Long term Capability - We ship millions of parts in a year Capability, Accuracy and Stability - Processes, Machines, etc. 7
K Internal Audit CAR - How Long for Responses to be Received? Internal Auditing 8
A Short Term vs. Long Term SPC Study - Where is Cp and Cpk Defined Statistical Analysis Tools, Techniques and SPC 8
B Control of Duplicate Documents - Limited Scope (long) Document Control Systems, Procedures, Forms and Templates 5
Proud Liberal How long does your company take to close an 8D on average? Problem Solving, Root Cause Fault and Failure Analysis 12
D Long length measurement of 18" up to 100" with an accuracy of .005 min General Measurement Device and Calibration Topics 8
M Is calibration from long ago still valid on never used pipettes? General Measurement Device and Calibration Topics 8
S How long should it take to get new TS 16949 certificate? IATF 16949 - Automotive Quality Systems Standard 1
M How long should AS9100 Certificate issuance take? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
Marc A silk casing enables long-lasting, implantable Wi-Fi medical devices Other Medical Device and Orthopedic Related Topics 1
L Medical Device New Product Design & Development- How long does this process take you? Other Medical Device and Orthopedic Related Topics 1
G SDS (Safety Data Sheets) Records - When and how long? Occupational Health & Safety Management Standards 8
B Long Term Process Capability from miltiple Machines and Fixtures Capability, Accuracy and Stability - Processes, Machines, etc. 3
O Takt Time Calculation for Long Runner Product Lean in Manufacturing and Service Industries 5
W AS9100C registration - How long does the system have to run before initial audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
M Corrective action on Non-conformances from a long time ago ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A Pre-clinical Animal Studies for long term implantable medical devices EU Medical Device Regulations 5
R Long Range OC Curves - Acceptance Sampling Switching Rules Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
kedarg6500 Sample Size for Short Term & Long Term Process Capability Capability, Accuracy and Stability - Processes, Machines, etc. 2
V How long can a development stage incident be open? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
D How long must we provide service parts to Ford? IATF 16949 - Automotive Quality Systems Standard 7
S What documents/records should we be retaining and for how long? Document Control Systems, Procedures, Forms and Templates 6
AnaMariaVR2 Dirty Medicine - Long-term criminal fraud at Ranbaxy Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 5
R Does long-term body worn medical monitoring device need to meet IEC 60601-1-11? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Wes Bucey Discrimination against long term unemployed Career and Occupation Discussions 2
C How long does AS9100 QMS need to be in place before the Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
5 5S Coordinator (Long-winded) Job Title Career and Occupation Discussions 8
L How long can the sample for Bio-Burden Test be kept? Other ISO and International Standards and European Regulations 4
D ECG Electrodes - Duration of Use (How long they are expected to stay on the patient) Other US Medical Device Regulations 2
C Help a beginner in the CE Marking world! (Semi long post) CE Marking (Conformité Européene) / CB Scheme 2

Similar threads

Top Bottom