Approving Consulting Firms in a Medical Device Company

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texkb

The company I work for is certified under ISO 13485 and we are currently working on getting ready to sell our device oversees. In getting ready to sell our device oversees we are beginning to work with consulting firms to help consult us on health care systems in Europe. These firms are basically consulting with us on how to get our device approved under for sale/reimbursement under local health care systems. My question is do we need to approve consulting services through our approved supplier process or is it not necessary to approve this type of service?

Thanks
 
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Marcelo

Inactive Registered Visitor
Re: Approving Consulting Firms

You do need to evaluate all services and product suppliers and approve them before using them, including consulting services.
 
T

texkb

Re: Approving Consulting Firms

Marcelo thanks for your input I figured this would be the cast but just wanted to confirm before going through the approval process. Another question that has come up is that in our product we have several specialized pieces which we have detailed technical drawings for. However, we also buy several "off the shelf" electronic parts. With the electronic parts we do not have any technical drawings instead we basically say that since is is an off the shelf part we will accept the manufacturers drawing and specifications as our specifications for that part. Is this acceptable under ISO 1345 or do we need to have technical drawings and specifications for these off the shelf electronic parts?
 

Ronen E

Problem Solver
Moderator
Re: Approving Consulting Firms

You do need to evaluate all services and product suppliers and approve them before using them, including consulting services.

AFAIK, only those that directly affect the quality of the final product (or service) that your company places on the market.

For example, if you purchase light bulbs for the company's accounts office, you don't have to evaluate the supplier...
 

Marcelo

Inactive Registered Visitor
Re: Approving Consulting Firms

Another question that has come up is that in our product we have several specialized pieces which we have detailed technical drawings for. However, we also buy several "off the shelf" electronic parts. With the electronic parts we do not have any technical drawings instead we basically say that since is is an off the shelf part we will accept the manufacturers drawing and specifications as our specifications for that part. Is this acceptable under ISO 1345 or do we need to have technical drawings and specifications for these off the shelf electronic parts?

You do not have to have your drawings if you buy parts from a supplier. However, you do have to be sure that their products are in accordance with what you need - your requirements. So you have to make sure that their drawings and specifications are in accordance with what you need. Depending on the how critical the components are, you could just have a general specification (for example, a resistor according to standard IEC XXX with YYY Ohms and ZZZ current and BBB voltage capacity), and that would in principle be ok. However, if the component is critical you might even need to inspect their drawings and specifications BEFORE you even think about using them as your supplier.
 
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Marcelo

Inactive Registered Visitor
Re: Approving Consulting Firms

Quote:
Originally Posted by mmantunes

You do need to evaluate all services and product suppliers and approve them before using them, including consulting services.
AFAIK, only those that directly affect the quality of the final product (or service) that your company places on the market.

For example, if you purchase light bulbs for the company's accounts office, you don't have to evaluate the supplier...

You are right, Ronen, I implied that but maybe i should've said it anyway.
 
T

texkb

Re: Approving Consulting Firms

Thanks Again Marcelo. You are correct that even though we are ordering off the shelf items the off the shelf items we are ordering are very specific, such as a Resistor, Thick Film, 100k, 1%, 100mW, 0402. And we do have the exact details of each electronic component listed. So after reading your reply and another apply to my thread on this topic I do not think we need the drawings for these items since we have such a detailed description of the product we are ordering. Even thought it is a detailed product and we don't necessarily need the technical drawings would it be wise to have the suppliers specifications on file for each of the electronic components?
 

Wes Bucey

Prophet of Profit
Re: Approving Consulting Firms

Marcelo thanks for your input I figured this would be the cast but just wanted to confirm before going through the approval process. Another question that has come up is that in our product we have several specialized pieces which we have detailed technical drawings for. However, we also buy several "off the shelf" electronic parts. With the electronic parts we do not have any technical drawings instead we basically say that since is is an off the shelf part we will accept the manufacturers drawing and specifications as our specifications for that part. Is this acceptable under ISO 1345 or do we need to have technical drawings and specifications for these off the shelf electronic parts?

You do not have to have your drawings if you buy parts from a supplier. However, you do have to be sure that their products are in accordance with what you need - your requirements. So you have to make sure that their drawings and specifications are in accordance with what you need. Depending on the how critical the components are, you could just have a general specification (for example, a resistor according to standard IEC XXX with YYY Ohms and ZZZ current and BBB voltage capacity), and that would in principle be ok. However, if the component is critical you might even need to inspect their drawings and specifications BEFORE you even think about using them as your supplier.
To follow the dictates of both FAA and FDA regarding off-the-shelf components of our products, we simply got copies of the engineering drawings (most recent version corresponding with our purchase.) We simply "adopted" the supplier's drawings and specifications into our system, using them for inspection purposes when accepting delivery of the components.
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I agree only products which are incorporated into YOUR product need such rigor in affirmation.

Further, it is not really so much following the Standard or the Regulation so much as using good business sense in affirming any product incorporated into your product.
Added in edit:
Good business sense also dictates you should thoroughly vet ANY consultants or services you hire for your business. Two big worries with consultants:
1) the consultant doesn't know the MINIMUM requirements

2) the consultant "invents" requirements far beyond the requirements of regulations or Standards ["mission creep"], either to cover his butt or to increase the number of hours to earn fees
 
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H

htquality

Re: Approving Consulting Firms

Hello,
In our case, we do not "evaluate" or "approve" consultants that offer the type of services that you mentionned, since they do not affect the quality of our product. However, we perform a thourough evaluation of our european distributors since they will be handling product...
 
T

texkb

Re: Approving Consulting Firms

To follow the dictates of both FAA and FDA regarding off-the-shelf components of our products, we simply got copies of the engineering drawings (most recent version corresponding with our purchase.) We simply "adopted" the supplier's drawings and specifications into our system, using them for inspection purposes when accepting delivery of the components.
\
I agree only products which are incorporated into YOUR product need such rigor in affirmation.

Further, it is not really so much following the Standard or the Regulation so much as using good business sense in affirming any product incorporated into your product.
Added in edit:
Good business sense also dictates you should thoroughly vet ANY consultants or services you hire for your business. Two big worries with consultants:
1) the consultant doesn't know the MINIMUM requirements

2) the consultant "invents" requirements far beyond the requirements of regulations or Standards ["mission creep"], either to cover his butt or to increase the number of hours to earn fees
Thanks for the information Wes. We have not been examined by the FDA yet but we are anticipating that we will be examined within the next year. So we will need to start preparing to have documentation to show that we are compliant with their standards as well.

In terms of the consulting services we do make sure we do our due diligence to ensure the people we are selecting are appropriate. In this case the consulting service we are using in Europe was referred to us by our legal service that we use in the US. So even though our CEO and our head of International Marketing are doing their due diligence to ensure the firms we are using are in fact knowledgeable of the requirements do we need to document this to comply with ISO 13485 and FDA?
 
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