General QMS questions in regard to Medical Software

[JeanG]

Hi, this is my first post here, I am working in a medical software company based in Ireland, they are producing online software service to Hospital, Pharmacy, GP,etc.
The software systems are a combination of:
1 Reading data (blood pressure measurements) from a range of BP monitors. Our software interprets that data i.e. provides a report on the levels of hypertension recorded. We have a scientific paper from an independent study which shows that our software interprets 24 hour BP data more accurately than the experts.


2 Interprets medical information manually entered by medical personnel and to help them to make diagnostic decision.

The questions are ,my boss always emphasises on that it's an online software system, we don't have packaging and labeling, no advisory notice and recall service, We don't do calibration, So Do i need to implement ADVISORY NOTICES, PACKAGING AND LABELING, 7.6 CONTROL OF MONITORING AND MEASURING DEVICES?

In addition, how should i do with 7.5.3.1 Identification and 7.5.3.2 Traceability and 7.5.3.3 Status Identification ?

Many thanks for all helps

 

[somashekar]

Hi, this is my first post here, I am working in a medical software company based in Ireland, they are producing online software service to Hospital, Pharmacy, GP,etc.
The software systems are a combination of:
1 Reading data (blood pressure measurements) from a range of BP monitors. Our software interprets that data i.e. provides a report on the levels of hypertension recorded. We have a scientific paper from an independent study which shows that our software interprets 24 hour BP data more accurately than the experts.


2 Interprets medical information manually entered by medical personnel and to help them to make diagnostic decision.

The questions are ,my boss always emphasises on that it's an online software system, we don't have packaging and labeling, no advisory notice and recall service, We don't do calibration, So Do i need to implement ADVISORY NOTICES, PACKAGING AND LABELING, 7.6 CONTROL OF MONITORING AND MEASURING DEVICES?

In addition, how should i do with 7.5.3.1 Identification and 7.5.3.2 Traceability and 7.5.3.3 Status Identification ?

Many thanks for all helps

~~~ Welcome to the COVE JeanG ~~~
Advisory notices is a part of improvement and would not be a part of routine operational step. Since you are online, your advisory notices can also be online as and when necessary. You need to maintain a documented procedure which details how you will issue and implement advisory notices at any time as necessary.
At any defined point of time gone past, can be be able to state which version of your software was operational... Labelling.
You do not have any goods for packaging, but the integrity and security that are offered to your customers for good and safe use of the software can be your packaging.
When you do not have and use any monitoring and measuring devices for sure., claim exclusion with due justification...

 

[JeanG]

Thanks for your help, it is so useful, I came up some new questions if you don't mind to check it out.
1. as a software company, I suppose we don't need batch record, what is batch record exactly?
2. Iso13485 says the organisation shall establish and maintain a record for each batch of medical devices that provides traceability to the extent specified in 7.5.3 and identifies the amount manufactured and amount approved for distribution. Is this applicable for us? or how should I implement this ,Do you have any templates?

Thanks again for all your help.

 

[somashekar]

Thanks for your help, it is so useful, I came up some new questions if you don't mind to check it out.
1. as a software company, I suppose we don't need batch record, what is batch record exactly?
2. Iso13485 says the organisation shall establish and maintain a record for each batch of medical devices that provides traceability to the extent specified in 7.5.3 and identifies the amount manufactured and amount approved for distribution. Is this applicable for us? or how should I implement this ,Do you have any templates?

Thanks again for all your help.

Each and every s/w service that is provided is a batch in itself. I am sure you will have records, and your own method to keep them saved.
Your method of your record maintenance is your own good template.

 

[sagai]

One label I think you certainly have regardless it is an on-line software, is the "About" box or the place where you have affixed the CE mark itself in your software.
(and probably the release notes, however I need to check that later)

Measuring device is a tricky one for software, sometimes test data considered as such if applicable.

 

[rob73]

Jean
The europa website has this guidance document for software, it may or may not be of use to you.
http://ec.europa.eu/health/medical-devices/files/meddev/2_1_6_ol_en.pdf

 

[JeanG]

Thanks for your help. They are so useful, anyone has an idea in regards to the sample audit question

8.2.4 q3, How is evidence of conformity with acceptance criteria maintained?

8.2.4 q4, Can you show me records that indicate who has authorised release of product to the next stage of the process? What kind of records should I have here, anyone has an example?

8.3 q3, Can you show me records of the identify of personnel authorising concessions? I have no clue what should i do to meet this requirement?

In general, if anyone who experienced monitoring and measurement of product in a software company, can you give me some advice how should i create a documented procedures, these software engineer in my company is too busy, the boss said they don't even have a time to say hello to me.

 

[edgar123]

Thanks for your help. They are so useful, anyone has an idea in regards to the sample audit question

8.2.4 q3, How is evidence of conformity with acceptance criteria maintained?

8.2.4 q4, Can you show me records that indicate who has authorised release of product to the next stage of the process? What kind of records should I have here, anyone has an example?

8.3 q3, Can you show me records of the identify of personnel authorising concessions? I have no clue what should i do to meet this requirement?

In general, if anyone who experienced monitoring and measurement of product in a software company, can you give me some advice how should i create a documented procedures, these software engineer in my company is too busy, the boss said they don't even have a time to say hello to me.

Hi JeanG,

When dealing with such question it's always tricky because we're dealing with monitoring during "product realization".
So, I'm curious to read what the experts here think about what is "product realization".
It could be simply verifying that the software shipped is the exact same as the one designed or one could consider coding as the "production" itself and then it's a complete different story (test cases verification are viewed as different steps for monitoring of the product).
Personally I used to follow the first path.
Then...
8.2.4 q3: a checksum could be an example on some parts of the code and eventually a functional test with the system recorded in the DHR is another way
8.2.4 q4: in the DHR there may a section for the signature of the person who authorizes the release. In the previous question's case the software engineer or any authorized person (as per job description) would just sign the execution of the test
8.3 q3: on the concession form there should be a section to document the identity of the person authorizing it. Mainly here the authorized person must be the one able to confirm that all regulatory requirements are met (RA usually)

 

[lyang]

Labeling is defined in two areas of FDA Regulation 21 CFR 820 subpart K Labeling and Packaging control. In addition, labeling is also defined in 21 CFR 801. In interpretation by the FDA for labeling is article written or unwritten on your website, marketing literature, emails to consumer, conversation, etc... A recent case I can recall is the Pfizer 2.3billion case where their sales force were promoting off-label use verbally. Yes, they got slapped hard. In all when I crunched the numbers, Pfizer came out in the black still so companies will play loosey goosey when it's profitable.

In 2011, FDA released a draft guidance on mobile medical device. I would check it out since your application is definitely a medical device and is offer through the cloud.

http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/UCM263366.pdf
In response to your main questions.

1) Yes you need labeling. That's what your website is for.
2) You may not need calibration of your device if the method need not to be calibrated, but certainly a test method validation, data integrity validation, data security, electronic signature, including software validation to show that calibration is not necessary because X. Lastly, you need to validate the software as you go live.
3) Advisory notice. Yes. what happens if your software makes a wrong conclusion? What will be your process to notify your customer and the patient? This makes sense business.
4) Most modern relational database uses a unique key and as long as you track changes, this should be done. In addition, software versioning is key. Your firm cannot willy nilly update software without first testing it.

A company doing something similar in another field of medicine that comes to my mind is vRad. I would touch base with their people. Mobile medical software is something the FDA is concern about...because our economy is not fully recover, the FDA is less aggressive against companies at the forefront of technology. Once mobile medical software have been around for a while, I can certainly see the FDA pulling this category into the fold quickly.

Update: I thought about deleting my post because it's irrelevant to the OP's market (EU). However, it may be of use to the OP in the future if they seek FDA clearance.