ISO 13485 Risk Analysis - Class II Medical Device Engineering Changes

I am Al.
I work for a medical device company making Class II medical devices. The company is situated in San Jose, Ca. I am relatively new to the medical device industry, and I am tasked with the regulatory aspects of the business. I have been looking at many of the posts regarding ISO-13485.
My question is engineering made a change to the product by adding a conformal coating to the PCB to prevent damage from moisture. My question is do you have to go through all the risk analysis process to justify this change that it is safe or is there a simple way to perform a risk assessment and document that. The reason for the change was data from customer returns which showed damage to the product from some type of liquid. Any help is appreciated.

Al

Ammend your risk management file by doing an evaluation of the impact of the change. One the sections of the ISO 14971 standard refers to materials that may come into contact with the patient. If there is a chance for that you may want to consider the need for Biocompatibility testing. Also consider the risk of fumes if the coating overheats and the possible impact on the environment. Since your equipment is electronic or contains electronic components then you may need to review ISO IEC 60601-1 too

Thanks for the reply Arios, very helpful.

Do you have any idea what other factors should be considered for the evaluation. This material soed not come in contact with human tissue at all. This material is stable over a high temperature range for the normal operating temperature of the product, but for fault condition where a component heats up I dont know what it does. may have to contact the manufacturer of the material.

Thanks in advance

Al

You have to evaluate if you change introduced a new hazardous situation or if it changes any estimate, probability or severity, on all the previously identified hazardous, if your following ISo 14971. So, there´s no easy way, you have to do this iterative risk analysis process.

Please also read following FDA guidance document for regulatory consequences: Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1)

By virtue of your feedback system flagging a problem which initiated you to take action, You need to update your risk analysis anyway . At a minimum, Risk analysis should be updated to reflect the new failure/hazard and how you are mitigating. As Mmantunes stated, you need to evaluate if you are introducing new hazardous.

If this is US marketed product, make sure you are not required to file an MDR.

If this is US marketed product, I don't see the need to file a 510K since you haven't changed the intended use by your description. Your Quailty System should be adequate to document the change(assuming your quality system is adequate).

Thanks for the reply. I guess it all comes down to document the chaneg which we did. Th eother part if to look at any potentail new hazards which migh develop because of the change.

albet88 said:

I am Al.

Click to expand...

We can call you Al? I know a song about that.

I work for a medical device company making Class II medical devices. The company is situated in San Jose, Ca. I am relatively new to the medical device industry, and I am tasked with the regulatory aspects of the business. I have been looking at many of the posts regarding ISO-13485.
My question is engineering made a change to the product by adding a conformal coating to the PCB to prevent damage from moisture. My question is do you have to go through all the risk analysis process to justify this change that it is safe or is there a simple way to perform a risk assessment and document that. The reason for the change was data from customer returns which showed damage to the product from some type of liquid. Any help is appreciated.

Al

Click to expand...

Just to back up the previous good posts, you need to review as much of the RA as appropriate. To be honest, that is indeed probably all of it, but you should be able to go through it quite quickly, as you can rule out many possible hazards quite quickly.

I would avoid assuming "it's only a coating, there's no risk", Alberto gave some good examples of possible risk impacts that are very different.

There´s also a new NB-MED guidance which can help in this case: NB-MED2-5-2Rec2-Reporting of design changes and changes of the quality

Also, you should have initiated an ECR / ECO (engineering change request / order) for this change. If you didn't prior to making the change, you may need to do a C/PA. I am commenting from experience.