Regulations concerning Calibration of Stop Watches used for Testing Medical Devices

P

Phalcon

#1
I am trying to find regulations concering the need for calibration of stop watches used for testing medical devices. There is some debate in my organization if it is required or not. Any information would be very helpful.
 
Elsmar Forum Sponsor

rob73

looking for answers
#2
Re: Regulations concerning Calibration of Stop Watches used for Testing Medical Devic

If you are using the stopwatches for inspection/verification/production purposes then they should be calibrated as should any instrument used for measuring. A calibration procedure should be easy enough,our NB once suggested that if we needed to calilbrate we could use either radar controlled clocks (traceable to national standards) or use the speaking clock and write our own procedure.
We did away with the timing issue so we never had to pursue it;)
Rob
 

ScottK

Not out of the crisis
Leader
Super Moderator
#3
Re: Regulations concerning Calibration of Stop Watches used for Testing Medical Devic

What Rob73 says above - if you are using it for verification of product/process or for validation of a process it should probably be calibrated whether you're in medical devices or not.

As far as a program - You can get a digital stopwatch with a NIST traceable cert for under $40.00 from Cole Parmer.
I'd probably buy one and replace with another on an annual basis.

(I used to have a couple really good calibrated Meylan stopwatches. Wish I knew what happened to them)
 

ScottK

Not out of the crisis
Leader
Super Moderator
#4
Re: Regulations concerning Calibration of Stop Watches used for Testing Medical Devic

What Rob73 says above - if you are using it for verification of product/process or for validation of a process it should probably be calibrated whether you're in medical devices or not.

As far as a program - You can get a digital stopwatch with a NIST traceable cert for under $40.00 from Cole Parmer.
I'd probably buy one and replace with another on an annual basis.

(I used to have a couple really good calibrated Meylan stopwatches. Wish I knew what happened to them)
PS - as far as regulations... ISO13485, for example, requires measurement equipment to be calibrated or verified at specified intervals....etc...

You need to determine determine if the device is use "to provide evidence of conformity of product to the determined requirments"
That's whether it's a watch, caliper, balance, etc.

If you're making something that dispenses X ml of fluid per hour and you're using a stopwatch to verify... I'd say "yes"
 
P

Phalcon

#5
Re: Regulations concerning Calibration of Stop Watches used for Testing Medical Devic

Thanks Rob73 & ScottK, these are the exact points I have been making. I appreciate the help.
 
Thread starter Similar threads Forum Replies Date
Q Brief overview of Standards and Regulations concerning Breast Implants Other Medical Device and Orthopedic Related Topics 2
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
G Regulations for research products in Europe EU Medical Device Regulations 0
J Applicable Great Britain regulations for a custom-built test rig or evaluation kit used for research purposes only. Design and Development of Products and Processes 0
E The FDA regulations (21 CFR 312.3): Is it allowable that IND sponsor involves more than one individual or organization? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
A Korean KGMP regulations on facility relocation Other Medical Device Regulations World-Wide 5
G Brazil Regulations RDC 270/2019 Other Medical Device Related Standards 0
G No new regulations in Austria medical device register after 26th Mai, 2022 EU Medical Device Regulations 0
C Is there a list of products or classifications subject to medical device regulations in El Salvador? Other Medical Device Regulations World-Wide 0
B Rework of a medical device EU regulations EU Medical Device Regulations 5
L Single-cell lithium ion battery regulations IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
L Saudi regulations for Japanese non sterile scopes Japan Medical Device Regulations 0
L ANVISA’s RDC 665 replaces previous regulations including RDC 16/2013 and IN 08/2013, and comes into effect on May 2, 2022 Other Medical Device Regulations World-Wide 1
M Seeking mentor/consultant for orthopaedic soft goods regulations Job Openings, Consulting and Employment Opportunities 0
D Regulations covering Sterile product shipments ISO 13485:2016 - Medical Device Quality Management Systems 1
R Medical device regulations in African countries Other Medical Device Regulations World-Wide 1
R Regulations on Controlled Document Size (Paper Size) Document Control Systems, Procedures, Forms and Templates 4
Z Swiss Authorized representative & non-medical device regulations Other Medical Device Regulations World-Wide 0
N How to validate Regulations and Standards? ISO 13485:2016 - Medical Device Quality Management Systems 12
G How to record Regulations and Standards as Design Inputs? Design and Development of Products and Processes 15
L EOL milestone in Medical Devices Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 1
dgrainger Informational DRAFT: The Medical Devices (Northern Ireland Protocol) Regulations 2021 UK Medical Device Regulations 1
B Regulatory Affairs Certification (RAC) Book - Fundamentals of Medical Device Regulations Medical Device and FDA Regulations and Standards News 0
J In-house (NHS) manufacture and use (by staff) of non-medical devices.. any regulations apply? UK Medical Device Regulations 6
N Competitor not complying with regulations (EU) EU Medical Device Regulations 1
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
V Regulations renewal IATF 16949 - Automotive Quality Systems Standard 1
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
M Labelling - Is there a guidance or regulations that specifically defines the 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Draft of New UK Regulations? UK Medical Device Regulations 2
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Warehousing two separate components to a finished device while meeting regulations Other US Medical Device Regulations 7
M Find updates to REACH and Rohs regulations REACH and RoHS Conversations 1
S Is QMS like a set of rules and regulations that a company follows? ISO 13485:2016 - Medical Device Quality Management Systems 10
M Brexit The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 UK Medical Device Regulations 1
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
N Where to find Regulations for Reprocessing and Reuse of Single-Use Devices Other Medical Device Related Standards 2
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
7 Iraq Medical Device Chemical Regulations Other Medical Device Regulations World-Wide 0
T Conflict Mineral Regulations Reliability Analysis - Predictions, Testing and Standards 1
M Is There a Revision History or Change Log for Canadian Regulations? Canada Medical Device Regulations 3
J Interesting Discussion Compliance with regulations in exceptional circumstances EU Medical Device Regulations 5
M Status of Medical Device Regulations in UK Post-Brexit Other Medical Device Regulations World-Wide 10
G App - Local regulations applicable EU Medical Device Regulations 2
Pmarszal External Standards and Regulations Management Process Document Control Systems, Procedures, Forms and Templates 10
M Advertising medical devices in the U.S - Advertising regulations or guidance documents Other US Medical Device Regulations 3
T Confirming The Local Safety Regulations for Equipment - I'm in Malaysia General Measurement Device and Calibration Topics 1
Q Regulations for Medical Device Kit for Training Personnel? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

Similar threads

Top Bottom