I am in need of a ISO 13485 documentation template package. We are developing a Class II device and need to build a system quickly and efficiently. Any suggestions would be greatly appreciated.
We are not in a rush, but the company previously had consultants in that developed 'plans' and not procedures. There was a great deal of $$$ and time (18+ months) wasted. Parts of the system they implemented are salvagable, but not enough to encompass a whole system. Our device is software only so it is unique.
A good example is that the consultants had been training personnel and had DCO released a training form, but there is no training procedure (even a draft).
OK. We can help!
Just answer a few questions and we can narrow down what you need.
- Do you know WHY your company needs the ISO 13485 documentation template package? (I get the sense you are asking for "plug and play" documents which just need a few blanks filled in.)
- I presume your company wants to get ISO 13485 registration to take advantage of the "harmonization" rules laid down by regulatory authorities in various countries which allow a registrant to easily sell medical device products in their counties. Is this true?
- Has the company decided on a registrar to provide registration?
- Where does your company stand with the USA FDA regarding the medical device software?
- About how many employees are involved in the development of the device? How many employees in the entire company?
- Has the company been in business long or was it created primarily to develop this product?
- Does the company have any other products in production or development (regardless whether they are medical devices) or is this a single product company?
- Would your company be amenable to engaging in a no-obligation interview with an experienced, qualified (really qualified) consultant who would, if hired, be able to lead them through FDA and ISO 13485 registration?
- You write "need to build a system quickly and efficiently" - what do you mean in terms of time? days? weeks? a month or two?
The point of these questions is there is no "one size fits all" documentation package available anywhere that will adequately prepare an organization for the rigors of FDA and ISO 13485 registration. If the organization has not reached the point of running a business
without the documentation, adding generic documentation at this point would set them back, not advance them toward registration.
If a previous "consultant" (
probably doesn't fit MY description of "consultant" see:
Consulting – Is it in YOUR Career Future?)
had been training personnel and had DCO released a training form, but there is no training procedure (even a draft). A "DCO" normally means a "Document Change Order" - if this is what you are referencing, how could you possibly have change orders BEFORE you had adequate documents

Based on your brief description, it seems there was a major mismatch between the person calling himself a "consultant" and your company and its management.

Maybe, just maybe, you and your company bosses should also read through this thread
Wes Bucey offers service as "Strategy Advisor" - Seeking Case Studies for Book - maybe you could be a chapter in my book!
