Justification for Exclusion of Design and Development

J

jennaleeb

#1
Hiya! Thanks to everyone who provides such valuable insight in this forum.

We are a small medical device company (1 product, 4 employees) and manufactures a device that is Class I sterile in the EU and Class II in Canada. We outsource all manufacturing processes to another ISO certified company.

We are in the process of setting up our quality management system and it has come to my attention that CAN/CSA-ISO 13485 permits manufacturers of Class II medical devices to exclude clause 7.3 - Design and development from the QMS, with justification(s), and Annex V of the MDD requires only production quality assurance system.

What does "justification" mean? Does anyone have an example? I assume "is not required by markets the product is sold in" is not good enough.

Thanks!
 
Elsmar Forum Sponsor
T

t.PoN

#2
I get that you don't do design of whatever sort, right? if that is the case then it would be quite simple.
A statement "The design process Clause 7.3 doesn't apply in your company scope and activities" will do the trick.
just make sure that the scope of quality manual is clear. for example "Manufacturing, distributing, ...etc"

but if you do a design, then it would depend on the process and the product
 
J

jennaleeb

#3
Thanks for your response t.PoN!

My confusion arises because we DO do design...but we design a product that is Class I (EU) and Class II (Canada) and these markets permit exclusion of design for these device classes.
 
T

t.PoN

#4
This is a point of view from ISO 9001, and not ISO 13485

What is the impact of design on final product and the customer? who claims responsibilities of the design? if there is effect, then i don't think you can exclude Design, even if the EU regulation doesn't have a design requirements.

it all goes back to the impact on product, and customer.

if it has none, then you can exclude it.

The popular example: the design is given to you by customer, then you can exclude design.

Another example: you have a product A that has been designed and being manufactured for a long time. there is no change in design. but you also have a research and development that design a new product B. you can exclude design but the scope should be on Product A and not product B.

what is your case exactly? why do you need to exclude design?
 
M

MIREGMGR

#5
You can only exclude activities from your QMS that you in fact do not do.

So: you don't need to have a servicing procedure if you don't have any products that require servicing.

But if you manufacture products, or arrange for someone else to manufacture them, someone had to design them. Either you have to be responsible for that design, or you have to control via procedures in your QMS the activities of whoever you contract with to do that design on your behalf.
 
J

jennaleeb

#6
Okay - so I suppose I was reading the regulatory standards incorrectly.

I was reading "in Canada For Class II devices the scope can exclude design.." as "this part of your QMS wont be audited". But I guess what it really says is "you can exclude design if you actually don't design anything".

Since we are responsible for design, we cannot exclude it.

Thanks everyone!
 
S

silentrunning

#7
Jennaleeb, who does the validation of your product? If it is of your design, does your company validate it?
 
J

jennaleeb

#8
Hi silentrunning,

Hmm, I suppose yes it is us. We have a very simple device, essentially a specimen collection device. We are part of some ongoing clinical trials that are investigating self-collection of vaginal samples. Our subcontracted manufacturers validate the sterilization process.

Is this what you mean?
 
#9
As per 21 CFR Part 820.30, only select Class I medical devices need to have Design Controls (see below) and if your device is not in the list, you can justify the exemption.

Design Controls apply only for the following Class I devices -

(i) Devices automated with computer software; and

(ii) The following devices -

Catheter, Tracheobronchial Suction.
Glove, Surgeon's.
Restraint, Protective.
Applicator, Radionuclide, Manual.
Source, Radionuclide Teletherapy

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=820.30
 
Thread starter Similar threads Forum Replies Date
SATHYABALARAMAN Exclusion of IATF 16949 Clauses - 8.5.5.1 & 8.5.5.2 & Justification IATF 16949 - Automotive Quality Systems Standard 9
J What would be the justification for exclusion of ISO9001 clause 7.5.1? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
J Justification for visual inspection ISO 13485:2016 - Medical Device Quality Management Systems 3
T Justification of use of non-harmonized standards for MDR conformity Other Medical Device Related Standards 12
somashekar Justification for Non-applicable clause at Stage 2, in clause 4. ISO 13485:2016 - Medical Device Quality Management Systems 11
T Justification of "Design Excluded" in IATF 16949 Design and Development of Products and Processes 5
M V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device) Design and Development of Products and Processes 2
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1
B Per 21CFR 820.198 (b) - Justification for no investigation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 22
M CER Adverse events - Justification of databases searched EU Medical Device Regulations 5
P IATF 16949 Clause 8.4.2.3 - Justification for non-certified suppliers IATF 16949 - Automotive Quality Systems Standard 14
O Statistical justification of sampling size in V&V tests ISO 13485:2016 - Medical Device Quality Management Systems 5
V Statistical basis and justification while comparing / changing sampling plans Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
J Calibration Justification - Requirements for Measurement with a Calibrated Device General Measurement Device and Calibration Topics 1
N Sample Size Justification for Medical Device Shelf-Life Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
M Justification for Not Having a Validation Plan for a Critical Process ISO 13485:2016 - Medical Device Quality Management Systems 4
B EMC Repeat Justification - Reducing NRTL testing required after modification of ME IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Biocompatibility omission justification for FDA 510(k) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
G Exemption Filing / Exemption Justification RoHS, REACH, ELV, IMDS and Restricted Substances 9
H Factory Dictated Sample Size Justification Statistical Analysis Tools, Techniques and SPC 9
S Justification of Lifetime of a Medical Device including Component Aspects ISO 13485:2016 - Medical Device Quality Management Systems 13
C Justification for No CAPA in Complaint Files Nonconformance and Corrective Action 24
Q Sample Size justification for IEC 60601-1 Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Wes Bucey A justification to take HR out of hiring Career and Occupation Discussions 3
S Establishing an MSA Plan and Justification Suggestions wanted Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
G Sampling Plan - Sample Size Justification for a Bottling Cleaning Process Validation Qualification and Validation (including 21 CFR Part 11) 2
M Justification for Month End Calibration Date Calibration Frequency (Interval) 24
X Justification of Decrease in Receivables, Increase in Negative Cashflows Coffee Break and Water Cooler Discussions 2
J Sampling Plan Justification and Rationale Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
S MDR (Medical Device Reporting) Justification - Canned Statements Other US Medical Device Regulations 2
P Out of Tolerance Gage - Justification for not Recalling Product Misc. Quality Assurance and Business Systems Related Topics 7
Wes Bucey Justification for organization's tax-exempt status? Funny Stuff - Jokes and Humour 1
C Looking for Skills Matrix & Justification of skill levels. Document Control Systems, Procedures, Forms and Templates 5
A Justification for not performing overseas supplier audit General Auditing Discussions 6
Q Justification/Rationale for not investigating a nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 19
P Reference Only Gages - "For Reference Only" Rationale (Reasoning/Justification) General Measurement Device and Calibration Topics 25
G Justification for Supplier Quality Engineer Career and Occupation Discussions 3
M Justification for not doing Gage R&R Studies Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 13
J Medical Device FMEA Occurence Rating Scale Justification FMEA and Control Plans 3
J Software Justification in a Lean Environment - Convincing Management Lean in Manufacturing and Service Industries 12
R Frequency of self control and costs - Justification for 4 Hours vs. Every Hour IATF 16949 - Automotive Quality Systems Standard 2
N CE Mark Auditing - All they had for CE was a written Technical Justification EU Medical Device Regulations 5
R Cost Justification Based Upon Intangibles - Cost of Quality Misc. Quality Assurance and Business Systems Related Topics 4
D Exclusion 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 5
S Exclusion of chapter 7.5 production for clinical investigation ISO 13485:2016 - Medical Device Quality Management Systems 1
P Exclusion of clause 8.2.3 Reporting to regulatory authorities ISO 13485:2016 - Medical Device Quality Management Systems 7
K Can I make an exclusion of Design and Development in ISO 13485:2016 if my product is not regulated ISO 13485:2016 - Medical Device Quality Management Systems 12
Z Why Control Limits are not the same depending on type of exclusion of data points Using Minitab Software 7
optomist1 Design Exclusion, but now we might have an outsourced Product Design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 6

Similar threads

Top Bottom