Where to buy "canned" Medical Device QMS Procedures and Documents

D

dspaul

#1
We are new to the medical device software area and was wondering if anyone out here know where we can purchase standard operating procedure templates to satisfy FDA as well as the IEC 62304 standards.

Any help would be greatly appreciated.
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
There are some companies that run AdSense advertisements here that I have noticed but off hand I can't recommend any specific company. I think Mastercontrol is one.
 
S

Spazz

#3
Our company bought a canned QMS from Emergo Group (which I neither recommend nor discourage :)).

The only thing about canned procedures is that they're one-size-fits-all and you may have to do extensive revising so that they work for you.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#5
Not many people here are "pro" canned quality procedures. My suggestion is for you to read some of the existing threads on canned procedures. If you do you will get an idea of the pros and cons.

I have never used any, but I have seen companies who have and were quite satisfied. I have also seen companies use them and totally botch things up costing them a lot of totally wasted time and money. My opinion is that they can be good for people who know how to tailor the canned procedures to their system, and who understand that the canned procedures are *examples* from which to learn.

The biggest failure mode is people (companies) who try to mold/design their systems to the canned procedures.
 

Wes Bucey

Prophet of Profit
#7
The reason many organizations consider "canned" documents to achieve registration or certification to a Standard or a regulatory body usually falls into one of two categories:

  1. BUDGET $$$: The time and effort to generate some "document" which the company only wants to fill in a requirement from a Standard or a regulatory body and has no intention of doing anything further except use the document as part of their submission for registration/certification. Thus they want a document they can process to "find and replace" a generic company name with their own.
  2. TIME CONSTRAINT: the company wants to get up and running ASAP and doesn't want to take the time to work out its own procedures, thinking they can just adopt some else's that successfully got certification.
The problem in both scenarios is that it takes someone with intimate knowledge of the regulations for certification AND the capabilities, capacity, and character of the company and its managers to successfully adapt the generic documents to accurately reflect what the company should be doing as the most efficacious and efficient system to produce its goods and services.

The point being that the company will fail certification/registration if a independent auditor comes in and notes the company does not actually follow the procedures set forth in the generic documents.

Alternately, the company may follow the procedures, but notice that many of them are just expensive "busy work" which erodes profits.

MY SUGGESTION:
If the company does not have a really knowledgeable person "with intimate knowledge of the regulations for certification AND the capabilities, capacity, and character of the company and its managers to successfully adapt the generic documents to accurately reflect what the company should be doing as the most efficacious and efficient system to produce its goods and services." then it should consider hiring a consultant who CAN get up to speed on the company system and make judicious decisions on adapting generic documents to BOTH fit the company's operation AND meet the certification/registration requirements.
 
W

WoodDuck

#8
Hello Despaul,
:bigwave:
We are also new to medical device and are consulting with Emergo Group for our QMS. It has been a lot of work and having someone to guide you through the grey areas helps. Whatever you do, have a clear understanding of what you expect to have when you are finished writing your procedures. Our approach was to spend as little as possible while still having personal guidance with our project. Rather than have a person on site observing and writing procedures, Emergo agreed to draft procedures and work remotely with us so we could tailor them to our exact requirements. We started out not realizing we needed a QMS that addressed the embedded software in our device. Software was outside the scope of our contract with Emergo, so we engaged another consultant, RTEmd, to assist us with the alterations to the QMS. It's been nice to see how two independent companies approach QMS development and I've certainly learned more, but there has been a cost and time factor that has not helped. Good Luck!

Jim
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#9
This is a little bit off-topic, but I think it may be informative. The word consultant is mentioned. The thing to remember about consultants is, consultants are a source of training. In other words if your company does not have a person who fully understands the requirements, a consultant is much like a very intense trainer.

An off topic example: I worked with a company which had no one who was proficient in GD&T. They accepted contracts with prints that no one there fully understood and - As one might think - They ended up with problems now and again. I hooked them up with a local lab who agreed to provide "consulting" in interpreting prints which came with quotes (or contract revision requests). The company should have had a person in their lab who was proficient in GD&T, but they chose not to hire such a person (too expensive). But - They did start using the fellow from the outside lab to review prints when a quote came in.

Whenever I do an implementation as a consultant, one of the first things I explain is there has to be a target person for me to work with to teach the requirements and how they relate to their company. A consultant should be, above all else, a trainer.

Just something to think about.
 
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