© Camensys, Inc. 2016-2019

All medical device manufacturers need to implement a quality system as per ISO 13485:2016 whether they are manufacturing a rubber tube, hospital bed, catheter, artificial heart or a software. Though FDA regulation 21 CFR Part 820 differs from ISO 13485:2016 in some areas, it is advisable to follow ISO 13485 for three major reasons:

  • ISO 13485:2016 is more robust and complete than 21 CFR Part 820. It has a stronger tie to risk management principles and ISO 14971.

  • ISO 13485:2016 is a global standard which means if you are compliant to this standard, you are ready for most other countries including Canada, European Union, Japan etc.

  • More importantly FDA is planning to adapt ISO 13485 for the quality management of medical devices. They are planning to announce this in the fall of 2019.

"Are you ready for FDA" is a single self-assessment consists of multiple questions covering the complete ISO 13485. This also includes questions to cover the readiness for SaMD manufacturers who use Artificial Intelligence and Machine Learning (AI/ ML) as per FDA’s recent guideline. Depending on your response on the state of your product and company – pre-market or post-market as well whether your device uses AI/ ML, the assessment will guide you to answer only the questions relevant for you.

Most of the assessment questions will provide a sliding scale to enter your organization’s preparedness and compliance to the topic of each question. You need to select a value between 0 and 10 to represent the preparedness and compliance. The total score will accumulate the marks you give for each question.

Please note that this is a comprehensive and serious questionnaire that requires your mindshare and time. Depending on the number of questions you need to answer, it can take 30 minutes to 50 minutes of time. You must complete it in a single session since there is no way to save the partially complete session. However, you can take as long as you want with several breaks in between.

 

If you are medical device software developer either as part of your medical device solution including hardware or your software is SaMD (Software as Medical Device) i.e. not dependent on a particular hardware you still need to follow ISO 13485. But if you are looking for languages referring to software development in the standard, you will be disappointed. All the different sections and sub-sections are to be interpreted for the medical device software manufacturer. Camensys, as the medical device software developer has interpreted all those sections, created Standard Operating Procedures (SOP) specifically for software development processes as per ISO 13485 and ISO 14971 and implemented them using a suite of integrated development tools, ALM tools and quality management system tool.

 

 

The following questionnaire are made specifically for medical device software development organization. If you are creating some other non-software medical device, it is not for you. This complete set of multi-choice questions cover all the sections of ISO 13485. After the self-assessment it will give you a very good gap analysis of where you are now and where do you need to be.

 

If you are thinking what if you do not follow this guidance and just continue the way you are operating today, I have a message for you - do not take the risk. After spending years in developing the most innovative software addressing a real medical problem, at the last moment due to non-compliance your product will not be approved for the market. This means your marketing plan and the window of opportunity is delayed for months and you have to document everything you are doing today but in retrospect with gaps in memory and reality.

 

If you already have an approved medical device and you did not go through all these requirements, I would say congratulation. But the next time you might not be that lucky. Especially if your product gets some complaints that attract FDA’s attention, they will do a full audit and you might have a bigger problem.

If your medical device software uses Machine Learning and other advanced AI methodology, there are some additional requirements for getting FDA approval. The questionnaire includes those requirements based on FDA’s early thoughts on this subject.

 

It might look a little intimidating, just like any other regulatory requirements look like, but there are ways to make your life much easier to implement these at a least cost and least overhead.

"Are you ready for FDA"

FREE Self-Assessment Questionnaire for

Medical Device Software and

Software as Medical Device (SaMD)

 

"Are you ready for FDA" is a single self-assessment consists of multiple questions covering the complete ISO 13485. This also includes questions to cover the readiness for SaMD manufacturers who use Artificial Intelligence and Machine Learning (AI/ ML) as per FDA’s recent guideline. Depending on your response on the state of your product and company – pre-market or post-market as well whether your device uses AI/ ML, the assessment will guide you to answer only the questions relevant for you.

Most of the assessment questions will provide a sliding scale to enter your organization’s preparedness and compliance to the topic of each question. You need to select a value between 0 and 10 to represent the preparedness and compliance. The total score will accumulate the marks you give for each question.

Please note that this is a comprehensive and serious questionnaire that requires your mindshare and time. Depending on the number of questions you need to answer, it can take 30 minutes to 50 minutes of time. You must complete it in a single session since there is no way to save the partially complete session. However, you can take as long as you want with several breaks in between.