How do I meet the Medical Devices Risk Assessment requirement?

Al Rosen

Staff member
Super Moderator
#11
Kari said:
As a contract manufacturer, we only build to specs provided by our customers (we do not do any design work) . For the most part, we assemble circuit boards, however we do have a couple of customers for whom we build finished devices.

Given this, we really have no idea of what the potential risks would be to patients if defects go undetected. Therefore, wouldn't it be logical/acceptable , for our risk management program to focus on minimizing risks to the product itself? (i.e., defect prevention, etc.)

Thanks for your assistance/advice.

Kari
If you are building a finished device, you know how it will be used. What is the nature of the device? For example: Does it apply any energy to the patient? If yes, then if a component in the device was an incorrect value or defective, would more energy be applied than was intended? Would this level of energy be dangerous? As was earlier sugegested in this thread, look at ISO 14971. If you are pursuing registration to ISO 13485, I think you will need to have some form of risk management in place. It may very well be in collaboration with your customer. Perhaps a discussion of this subject with your customer(s) may be helpful.
 
Elsmar Forum Sponsor
K
#12
I have purchased 14971, however much of it (it seems over 90%) has to do with how the device is designed, and the risks it discusses are with respect to patients.

Although we manufacturer some finished devices, we really have no idea what effects could be for patients. For example, if a device is intended to deliver a fluid, and an assembly defect would cause the device to malfunction delivering too much or not enough fluid, we have no idea what effect that would have, whether it is serious or not. We are not doctors or electrical engineers... we do know how to follow directions and put things together.

To me it seems that the bulk of risk assessment must be on the designer. They are the ones who seek product approval, work on cross functional teams, and finalize the design.

We do have controls in place to minimize risks to products, but I don't know whether we need to specifically call this out as "risk management"; really that is what our quality system is for.
 

Al Rosen

Staff member
Super Moderator
#13
Kari said:
I have purchased 14971, however much of it (it seems over 90%) has to do with how the device is designed, and the risks it discusses are with respect to patients.

Although we manufacturer some finished devices, we really have no idea what effects could be for patients. For example, if a device is intended to deliver a fluid, and an assembly defect would cause the device to malfunction delivering too much or not enough fluid, we have no idea what effect that would have, whether it is serious or not. We are not doctors or electrical engineers... we do know how to follow directions and put things together.

To me it seems that the bulk of risk assessment must be on the designer. They are the ones who seek product approval, work on cross functional teams, and finalize the design.

We do have controls in place to minimize risks to products, but I don't know whether we need to specifically call this out as "risk management"; really that is what our quality system is for.
And, risk management is part of your quality system.
The organization shall establish documented requirements for risk management throughout product realization.
Records arising from risk management shall be maintained (see 4.2.4).
Consider the possible errors/defects during production and the resulting effect on the performance of the product.
 

Jim Wynne

Staff member
Admin
#14
Al Rosen said:
Consider the possible errors/defects during production and the resulting effect on the performance of the product.
Al:
I'm going to take the opportunity to learn something on this one. As I stated earlier, I don't have experience in this area, but where does it say that the risk assessment has to take end-use into account? I'm not actually disagreeing with you, and I will advise the OP to take your advice, but how can there be end-use responsibility in a job shop beyond meeting customer specifications?
 

Al Rosen

Staff member
Super Moderator
#15
JSW05 said:
Al:
I'm going to take the opportunity to learn something on this one. As I stated earlier, I don't have experience in this area, but where does it say that the risk assessment has to take end-use into account? I'm not actually disagreeing with you, and I will advise the OP to take your advice, but how can there be end-use responsibility in a job shop beyond meeting customer specifications?
There are discussions of the subject in these threads:

http://elsmar.com/Forums/showthread.php?t=11124

http://elsmar.com/Forums/showthread.php?t=11012

http://elsmar.com/Forums/showthread.php?t=7381
 
K
#17
JSW05 said:
Al:
...where does it say that the risk assessment has to take end-use into account?
ISO 14971 defines risk as "the combination of the probability of occrence of harm and the severity of that harm". It goes on to define harm as "physical injury or damage to the health of people, or damage to property or the environment", The standard (4.2) also requires manufacturers to document intended use, and any forseeable misuses. The appendicies go into great detail about patient safety, physician input, etc. So the scope standard very definitely goes through end-use.

JSW05 said:
Al:
...how can there be end-use responsibility in a job shop beyond meeting customer specifications?
I'm just learning this standard, and as of yet have no experience with the registrars' interpretation regarding risk management, but I beleive the norm will end up being that risk management is to be implemented "as applicable". Contract manufactures who have no hand in the design aspects cannot be expected to be responsible for the end-user. That has to fall on whomever is responsible for obtaining regulatory approval for the device. As long as we do what we can to minimize the risk of letting out-of-spec product out the door, I believe we will be covered.

I guess I'll know for sure whether I am right or wrong in a few months.

Kari
 
K
#19
I didn't say that we have no regulatory requirements; I said only that we are not responsible for regulatory submssion/approval to market devices.

As a contract manufacturer, we absolutely have regulatory requirements regarding manufacturing. This is why we are pursuing 13485: to demonsrate conformance with Canadian MDR requirements, since our customer markets their devices in Canada.
 
Last edited by a moderator:

Al Rosen

Staff member
Super Moderator
#20
Kari said:
I didn't say that we have no regulatory requirements; I said only that we are not responsible for regulatory sumssion/approval to market devices.

As a contract manufacturer, we absolutely have regulatory requirements regarding manufacturing. This is why we are pursuing 13485: to demonsrate conformance with Canadian MDR requirements, since our customer markets their devices in Canada.
Your customer has to register to ISO 13485 and CMDCAS[size=-1] (Canadian Medical Devices Conformity Assessment System)[/size], but where does it say your organization does? I can't find it in the regulations. Your customer holds the license, not your organization. Is this a condition that your customer imposed?
 
Thread starter Similar threads Forum Replies Date
M Informational MDDI - It’s Time to Meet the Users of Medical Devices Medical Device and FDA Regulations and Standards News 0
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
J Canadian Medical Device License Requirements - What if we failed to meet it? ISO 13485:2016 - Medical Device Quality Management Systems 4
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
T Risks of failure to meet intended use ISO 14971 - Medical Device Risk Management 6
B Qualifcations of Staffing Agency Employees to meet job description General Auditing Discussions 6
F What to do when you don't meet the 1:10 ratio Measurement Uncertainty (MU) 3
Sidney Vianna 40 miles per gallon...on an airplane?!?! 65,000 ft altitude....with a propeller? Meet the Celera 500L Coffee Break and Water Cooler Discussions 1
M Informational Team-NB published a press release regarding the capacities of notified bodies to meet the sector needs Medical Device and FDA Regulations and Standards News 0
W AS9120B - How to meet clause 7 Support that covers 7.1., 7.1.1, 7.1.2, & 7.1.3? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
C Must your reference standard provider be ISO17034 certified to meet your testing lab's ISO 17025 certification requirements? Other ISO and International Standards and European Regulations 2
P REACH - A few of the hundreds components in my product no longer meet requirement REACH and RoHS Conversations 2
Wes Bucey International Manufacturing Technology Show - 10 September 2018 - Chicago (meet up?) Coffee Break and Water Cooler Discussions 6
BradM Where knowledge and industry meet... Coffee Break and Water Cooler Discussions 10
M Is referenced content sufficient to meet record content requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Label Translations - Translation procedure to meet the requirements of MEDDEV 2.5/5 ISO 13485:2016 - Medical Device Quality Management Systems 4
M Forced NOT to meet End Customer Expectations - Corrupt Third World Country ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Finding a Fixture Design Course to meet Customer Requirements General Measurement Device and Calibration Topics 3
B Risk Requirements to meet the explicit Risk Based Approach of ISO 13485:2016 Examples ISO 13485:2016 - Medical Device Quality Management Systems 21
alonFAI SMT machine specifications and performance meet the requirements for our production Manufacturing and Related Processes 2
M Finding parts to meet ISO 15001 (Anaesthetic and respiratory equipment) EU Medical Device Regulations 8
G Quality Policy... Meet Requirements? IATF 16949 - Automotive Quality Systems Standard 6
S AS9100 Foreword: Meet or Exceed customer & applicable statutory and regulatory req... AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
S What are the differences between Traditional 510(k) and a PMA to meet 21 CFR 814.20 ? Other US Medical Device Regulations 3
B What is the implication for someone who does not meet the 70% pass mark for QMS-Lead. Professional Certifications and Degrees 2
D Are we doing enough to meet Identification and Traceability 7.5.3 Requirements? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
AnaMariaVR2 DIY Fixes Don't Meet CGMP: FDA Slams Manufacturer for Fixes Involving Tape, Rubber Ba Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
I Recording of In Process Data to Meet FDA QSR 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Calibration system must meet ISO 10012, ISO 17025 or ANSI/NCSL Z540? ISO 17025 related Discussions 38
T How to meet the requirements of Environmental Conditions in a Laboratory General Measurement Device and Calibration Topics 11
B Selecting components to meet UL 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
Q How to meet Responsibility and Authority (Clause 5.5.1) Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Marc Business These Days - Maker's Mark waters down bourbon to meet demand Coffee Break and Water Cooler Discussions 11
S Verify Software System Testing: Verify that results meet the Pass/Fail Criteria IEC 62304 - Medical Device Software Life Cycle Processes 1
Y Can't meet PEAR goals because of Corporate MGMT... Quality Manager and Management Related Issues 10
R Does dental unit need to meet the requirements of clause 14 (PEMS)? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Bill of Material Content to meet Purchasing Requirements Manufacturing and Related Processes 2
K Weight Calibration to meet the Z17025 Standard ISO 17025 related Discussions 1
A Instructions for Use - Best Practice to meet all International Regulations ISO 13485:2016 - Medical Device Quality Management Systems 6
N RS485 stand to meet the EFT (Electrical Fast Transients) test according to IEC 60601 ISO 13485:2016 - Medical Device Quality Management Systems 3
GStough Human Capital: How to Meet Requirements of 7.6 (Monitoring/Measuring Equipment)? Service Industry Specific Topics 10
R Is any part of earthed (grounded) enclosure required to meet, say, 25A/0.1ohm? IEC 60601 - Medical Electrical Equipment Safety Standards Series 18
B Issue CAR (Corrective Action Request) When KPI Fails to meet Goal Quality Manager and Management Related Issues 8
Q How to meet Clause 7.1.2 Acceptance Criteria in ISO TS 16949 IATF 16949 - Automotive Quality Systems Standard 7
D How to meet AS9100 Electronic Signature Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T Quality Compliance Software to meet ISO 13485 QMS and 21 CFR 820 Requirements Quality Assurance and Compliance Software Tools and Solutions 3
R ISO 10012, ANSI/NCSL Z540, ISO 17025 reference meet ISO 9001 7.4.2 (a) intent? ISO 17025 related Discussions 13
J Continuous Improvement SOP - How to demonstrate we meet TS 16949 Clause 8.5.1 IATF 16949 - Automotive Quality Systems Standard 12
M What other standards meet AMS 6415? Various Other Specifications, Standards, and related Requirements 1
D Calibration Traceability meet AS9100C Requirement? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3

Similar threads

Top Bottom