SBS - The Best Value in QMS software

Should EMC (Electromagnetic Compatibility) Testing be performed In-House

B

Bunny

#1
We are a medical device manufacturer and often have to send devices to third party labs which is becoming expensive. We are considering establishing an in-house EMC lab. Can anyone provide advise? Thanks!
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
Re: Should EMC Testing be performed in-house

CE Marking in particular do not require that testing is done externally. You surely can test in-house, a lot of manufacturers do that.

However, there are some points to considers:

- you need to make sure that your lab really can perform all the necessary tests and have competent personal. Although not required, a certification by ISO 17025 could help show this.

- if you use standards to provide presumption of conformity, please remember that, unless you clearly defined that some tests are not use, the expectation is that you performs all tests and this in conformity with with the whole standard. I've seen some in-house testing which does not take all tests into consideration and thus were not acceptable in some situations.

- third-party testing is usually viewed as more "trustable" due to being performed by an independent actor. Although not true, that's how NBs tend to view it. So it would be better to ask your NB first if he would be OK with your in-house testing.
 
B

Bunny

#4
Re: Should EMC Testing be performed in-house

Would we need to purchase other standards besides the standards required for our medical device? For instance, would we have to purchase standards for test labs and test equipment?
 

somashekar

Staff member
Super Moderator
#5
Re: Should EMC Testing be performed in-house

We are a medical device manufacturer and often have to send devices to third party labs which is becoming expensive. We are considering establishing an in-house EMC lab. Can anyone provide advise? Thanks!
Have you considered the cost of establishing an in-house EMC lab against the third party labs costs ?
In these times when expertise is available and cash flow is tight and space is at a premium, I would look at strengthening my core strength and expertise and take assistance from outside experts (like the third party labs) on a longer period contracts with more better rates for both consultation and testing. EMI / EMC is a specialized area and the third party labs always have both resources of consultency and testing about this field.
Please look at EMI / EMC as an ongoing project in all your design and design change situations, and just not as testing. You will be beniftted in the long run.
 
B

Bunny

#6
Re: Should EMC Testing be performed in-house

Actually, I have. :lol:
I do not agree with this idea, but was asked to research it.
I have no problem hearing from you experts that this endeavor will be difficult or expensive. I still need find the facts and let management decide.
 

Marcelo

Inactive Registered Visitor
#7
We are Class I, we do not have a NB.
Ok, so this is worse then. I would say that it would be better to keep testing in a third party just to minimize any risk related to acceptance of the tests in the future.

You would need to purchase any standards, equipment and the like related to creating a lab.

An EMC lab could cost some millions of dollars, for example.
 
B

Bunny

#8
So far, Engineering manangement has figured $20,000. They are VERY willing to do it for that amount.
 

Marcelo

Inactive Registered Visitor
#9
Do you want to test which standards? I really cannot see how any emc standards, as easier as it is, needs equipment which costs only $ 20,000.

The last two labs that I know for medical device EMC in Brazil cost more than millions. They serve other purposes, also, but EMC equipment is fairly expensive (for example, you will need an aneichoic chamber. Depending on the size, only the EMC isolator material will cost you much more than $ 20,000)
 

CharlieUK

Quite Involved in Discussions
#10
You can't build a suitable facility for $20k.
$200k might get you something usable 2nd hand - but who is going to operate it / maintain it / keep it all caibrated and working.

Ways you can save money on testing are:
- do some pre-testing in-house - this can be done relatively inexpensively
- plan your testing - don't just ask the lab what to do, review the requirements yourself - or hire someone to write you a test plan - the directives require you to "apply standards" not "test against standards" - you can reduce test costs by putting more effort in else where.
- get multiple quotes from different labs - prices can vary by 50% for same tests.
 
Thread starter Similar threads Forum Replies Date
T How should I approach REACH, CM, etc. as a job shop? RoHS, REACH, ELV, IMDS and Restricted Substances 18
A Should we assign the PRRC before the date of application of MDR (26 May 2021)? EU Medical Device Regulations 0
J UDI-DI how should we interpret Device version or model to determine if a new UDI-DI is needed? EU Medical Device Regulations 0
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Should I take an online course for a career in Occupational Health and Safety? Career and Occupation Discussions 2
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
K Should APQP/PPAP has its own section in a QM? Quality Management System (QMS) Manuals 1
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
S Which Sampling Plan(s) Should I Use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Master Samples - What should we be keeping? IATF 16949 - Automotive Quality Systems Standard 9
G Supplier delivered recent PPAP, should he deliver yearly layout inspection? IATF 16949 - Automotive Quality Systems Standard 4
John Broomfield Vote - Should ISO9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Capability Study - in the beginning of your career what should you have known about the tool Quality Tools, Improvement and Analysis 11
J Should Loading and Unloading be Included in Cycle Times? Lean in Manufacturing and Service Industries 14
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
G Should I perform Gage R&R only at the beginning of a new project? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
J On PFMEA for danger labels - Label always should be assigned severity 10 ? FMEA and Control Plans 3
H Who should be listed as the manufacturer/distributor on the box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 3
BeaBea How Many Processes should be created for each Department? Process Maps, Process Mapping and Turtle Diagrams 5
M Should volume of sales be factored into risk probability assessments? ISO 14971 - Medical Device Risk Management 33
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5
M Which incubation condition should be selected to recover both bacteria and fungus effectively Miscellaneous Environmental Standards and EMS Related Discussions 3
D Is there a specific location for PPE such as safety glass holders and glove dispensers should be mounted Occupational Health & Safety Management Standards 10
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
M Who should receive the bills from suppliers and vendors, account payable or procurement? Consultants and Consulting 4
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
S Companies that maintain your machine should be in ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Use of "Shall" versus "Should" in Procedures ISO 13485:2016 - Medical Device Quality Management Systems 26
D Class II medical device - When should a complaint be closed? Customer Complaints 6
Sidney Vianna IATF 16949 News Presentations from the latest IATF Stakeholder Event - Expectation that IATF 16949 certification should equate with product quality. Misguided? IATF 16949 - Automotive Quality Systems Standard 7
L Clause 0.4 of ISO 9001 and EHS - Where should I stop the inclusion of EHS in my QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Ed Panek Part 11 Self Certify Memo - What else should it cover? Qualification and Validation (including 21 CFR Part 11) 5
H Should I mention machine/Equipment password In SOP? Qualification and Validation (including 21 CFR Part 11) 4
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
H Statistical Techniques Procedure - What should be included Document Control Systems, Procedures, Forms and Templates 4
Q How should I analyze measurement correlation between me and customer? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12

Similar threads

Top Bottom