Choose the minimalistic ones.
You goal is to pass your audit in the most efficient way possible. In the history of this planet, no company has ever received an award for lengthy compliance documentation.
Long Answer
Let me start with this: When you file your taxes, what's your goal? I'll give you two options to choose from:
- You want to get it done as fast as possible while doing everything in a legal way, because you'd like to move on and do other stuff during the short lifetime you have on this planet; or:
- You want to create the most beautiful, lengthy and elaborate tax return, because you think that writing the most beautiful tax return is a great idea.
What do you choose to do?
Most rational human being would choose option 1. - of course it's important to do everything in a legal way (you don't want to go to jail for tax avoidance!), but the outcome of filing your taxes is not a sliding scale, it's a yes/no result: Either you've filed your taxes, or you haven't. You don't get bonus points for filing your taxes in a beautiful way.
The same applies to medical device compliance. Let me translated the two scenarios into our industry.
Your goal is to bring your medical device to market. You have two options:
Most rational human being would choose option 1. - of course it's important to do everything in a legal way (you don't want to go to jail for tax avoidance!), but the outcome of filing your taxes is not a sliding scale, it's a yes/no result: Either you've filed your taxes, or you haven't. You don't get bonus points for filing your taxes in a beautiful way.
The same applies to medical device compliance. Let me translated the two scenarios into our industry.
Your goal is to bring your medical device to market. You have two options:
- You get it done as efficiently as possible while doing everything legally and ensuring that your medical device is safe. You it this way because your company only has limited resources (time, money) and medical device compliance is only one challenge of many - you also have to solve your product development and especially marketing and sales later. Or:
- You set out to craft the most elaborate, beautiful, lengthy quality management system (QMS) and technical documentation on this planet, because you think that's a great idea.
Depending on what your answer to the question above is (1 or 2), you should choose our templates for the templates of other consultants. Choose our templates if you want to get stuff done efficiently. Choose other, more lengthy templates if you have the irrational belief that longer documentation (and much more time spent on it!) somehow makes your life or your company better. It doesn't.
Audit Outcomes
Still not convinced? Let's look at some audit outcomes - many companies have passed audits with our templates already. Let me show you some typical outcomes.
Audit Outcome Of Lengthy Documentation
If you choose to do lengthy documentation, even then auditors will find something, because they always feel like they have to find something (this is common knowledge in the regulatory community). So you'll still get back a list of "findings" from your Notified Body, and you'll still have to work on that.
The problem was that you spent forever creating your lengthy documentation, yet you still get findings and have to hand in your documentation twice. No benefit.
The problem was that you spent forever creating your lengthy documentation, yet you still get findings and have to hand in your documentation twice. No benefit.
Audit Outcome Of Short Documentation
With short documentation, your immediate benefit is that you are much faster - I would estimate even 10x faster (see the table further below).
You next benefit is that you might get some findings from your auditors, but the good news is that you now know exactly where you have to improve your documentation - and auditors give you 3 tries for MDR submissions, and you can easily get everything right on your next try!
Or, put another way, if you didn't get many findings in your audit, that's a clear indicator that you over-engineered and wasted time.
You next benefit is that you might get some findings from your auditors, but the good news is that you now know exactly where you have to improve your documentation - and auditors give you 3 tries for MDR submissions, and you can easily get everything right on your next try!
Or, put another way, if you didn't get many findings in your audit, that's a clear indicator that you over-engineered and wasted time.
Efficiency Gains Of Short Documentation
In short (pun intended), choosing short templates is your biggest leverage for getting everything done - it might be around 10x as I wrote in my article on how long medical device compliance takes. Here's a table from that article:
You can see that other templates are ~9x more lengthy than ours, while the outcome is the same (you still pass your audit).
So you have to ask yourself: Is it worth it to you to do ~9x more work for the same result, only to feel a bit better? For rational people, the answer is "no", but some people might still say "yes". In that case, I can't help you. Good luck.
So you have to ask yourself: Is it worth it to you to do ~9x more work for the same result, only to feel a bit better? For rational people, the answer is "no", but some people might still say "yes". In that case, I can't help you. Good luck.