ISO13485 Clause exclusions for a Medical Software Company

J

jinggong

#1
Hi, Everyone,
I am very new to here, currently i am working as a regulatory affairs specialist in a medical software company based in Ireland. In order to achieve ISO13485, we are trying to implement all quality requirement, i wonder can someone advice me what clauses should be excluded as a software company? Some are definitely not applicable to us, such as

7.5.1.2.1 Cleanliness of Product and contamination Control
7.5.1.3 Particular requirements for sterile medical device
7.5.2.2 Particular requirements for sterile medical device
7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices

I wonder are there any more? what about 7.6 Control of monitoring and measuring devices, we don't do any calibration. Thanks in advance for any advice.
 
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J

jinggong

#3
Hi, that's right, stand alone software with online system, which means we don't really have the packaging or labeling.
Very simply our software systems are a combination of:
Reading data (blood pressure measurements) from a range of BP monitors

Thanks for your help in advance
 

DannyK

Trusted Information Resource
#4
Nonapplicable clauses could be:

7.5.1.3 & 7.5.2.2 - devices are not sterile
7.5.3.2.2- device is not implantable
7.5.1.2.1- cleanliness and contamination control
7.5.1.2.2- Installation- Is the software installed?
7.5.1.2.3- Servicing- Is the software being serviced?
7.6- Calibration- is their test software involved to determine that the software is working? If yes, do not exclude.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Are you sure it falls under the official Medical Device definition?

What does it do except reading data? What is it intended for?
 
J

jinggong

#6
Hi, is 6.4 Work Environment also a Nonapplicable clause? We don't do environmental control, no sterilization procedures involved, can i just stated general work environment, but there are no any documentation and work instructions
 
J

jinggong

#7
Hi, I am pretty sure it falls into medical device according to FDA'S definition.
It also interpret the data and provide report to assist the doctors/GP/Pharmacy to make diagnostic decision.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
What is the target market (i.e. regulatory domain)?
You mentioned FDA. FDA doesn't require ISO 13485; the applicable parallel is the Quality Systems Regulation (QSR) = 21 CFR 820.
I'm trying to figure out whether ISO 13485 is applicable to you at all.
 
J

jinggong

#9
Hi, Ronen,
The boss asked me to get CE, ISO13485 and 510K, ISO14971, I am just a recent graduated student from bachelor of Medical Device Innovation. I was wondering the same question before, but the company had ISO 9001 Certification back to few years ago, I knew that fDA doesn't need ISO13485, I just feel that we are close enough to ISO13485, I thought 21CFR PART 820 is very similar to ISO13485, I am trying to prepare the quality management system in compliance with both systems. Do you know under which circumstances that a company doesn't need ISO13485? My second question is should i develop two quality manual or just one quality manual meet both requirements?
Thanks for your time and patience. There are so much I have to learn it.
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Hi, Ronen,
The boss asked me to get CE, ISO13485 and 510K, ISO14971, I am just a recent graduated student from bachelor of Medical Device Innovation. I was wondering the same question before, but the company had ISO 9001 Certification back to few years ago, I knew that fDA doesn't need ISO13485, I just feel that we are close enough to ISO13485, I thought 21CFR PART 820 is very similar to ISO13485, I am trying to prepare the quality management system in compliance with both systems. Do you know under which circumstances that a company doesn't need ISO13485? My second question is should i develop two quality manual or just one quality manual meet both requirements?
Thanks for your time and patience. There are so much I have to learn it.
Hi,

1. IMO, a company "needs" ISO 13485 only when it makes finished medical devices (according to the definition applicable where it intends to market), and a clear external requirement exists - primarily a regulatory one, and in some cases also a customer's one. In all other cases companies don't really need ISO 13485 (certification).

2. IMO you better have a single quality manual that satisfies all applicable requirements.

3. Sometimes bosses need to be educated. I know it is tricky when you are a novice. I just mean that the mere fact that a boss wants something doesn't automatically make it a real, wise requirement. In some (bad) companies satisfying all your boss's requirements (or at least striving towards that) is a prerequisite to staying in the job; however, really good bosses prefer to be challenged as long as the challenge is friendly and made on a well-reasoned and well-informed basis. They benefit from it and the org benefits from it. In the long run, I can only recommend you try to work for a boss of the second type. Meanwhile, you probably need to stay cautious and accumulate experience on your resume.

4. CE is required for placing medical devices on the EC market. ISO 13485 is not mandatory for that purpose, but it can streamline the certification process (pay attention to the device classification). ISO 13485 may be a requirement in other domains (but not the USA). ISO 14971 compliance is not mandatory for ISO 13485 compliance and/or CE marking, but it may streamline the certification process (please note that as of about a year ago EN ISO 14971 has become a limited tool in complying with the MDD ERs). A 510k may be required for marketing in the USA, but it has much less to do with quality management systems.

5. ISO 9001 may be a good starting point to ISO 13485 / 21 CFR 820. In some cases you don't need to go beyond ISO 9001, even if you are serving the medical market.

6. 21 CFR 820 is similar to ISO 13485, but in my opinion there are some significant differences. Moreover, part 820 is a component that fits in the greater FDA scheme, with all its definitions and various requirements, guidances and tools. If you don't intend to market outside the USA in the near future, I strongly recommend you focus on this regulatory scheme first. Your effort will be more effective and you have better chances of achieving clarity and consistency. Expanding to other regulatory domains later may look less efficient, but IMO it is more effective in the long run (refer the hare and the tortoise).

Good luck,
Ronen.
 
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