Hello to all the Quality Gurus,

I am new to this thread and have been searching documents and information regarding Contract Manufacturing of Medical Device but have failed. Could anyone help me in this regards.

Thank you in advance.

Welcome,

What information exactly are you looking for? Is it control of sub-contract manufacturing of your designs or working as a sub-contract manufacturer for another medical device company?

Thank you for the reply.Is it about the control of sub-contract manufacturing of our designs.

Thank you for the reply.Is it about the control of sub-contract manufacturing of our designs.

Have you conducted a search on outsourcing?

Stijloor.

Thank you for the reply.Is it about the control of sub-contract manufacturing of our designs.

Do you have any systems currently in place?
Eg
Change control procedures (how, when & what situations the supplier is to notify you of process changes), process validation requirements etc

Have you conducted a search on outsourcing?

Stijloor.

I have but have failed to do so. Since I am just learning about Contract manufacturing I need to have knowledge regarding this issue.

Do you have any systems currently in place?
Eg
Change control procedures (how, when & what situations the supplier is to notify you of process changes), process validation requirements etc

No since I have just started learning about this topic I have no idea what it has to involve.
That is why I wantde to take help from this forum.

No since I have just started learning about this topic I have no idea what it has to involve.
That is why I wantde to take help from this forum.
It is about your extension of the quality management system to a place where he does exactly per your specifications. The capability and competency of the supplier to understand and bring to effect all techincal, commercial and regulatory requirements related to the process he is given to execute needs to be assessed. This is first in the evaluation and selection of source and later about monitoring supplies. Technical audits, management system audits, Assessment of infrastructure and maintenance of facilities, HR capability and training of his human resources could be typically considered along with sample evaluation, process capability and validation, and maintenance of records of supplies.
Does this guide you forward ...... ?
good luck

One of the best ways to control the subcontract of the manufacturing of your design is to create a written agreement with your supplier

The agreement would include issues such as:

1. Quality system requirements and notications of changes to the system
2. Right of access
3. Traceability requirements
4. Notification of nonconforming product
5. Changes to processes

As part of your internal audit, you may want to schedule an audit at the supplier on a periodic basis to ensure that they are following the requirements.

Hello to all the Quality Gurus,

I am new to this thread and have been searching documents and information regarding Contract Manufacturing of Medical Device but have failed. Could anyone help me in this regards.

Thank you in advance.

Wikipedia defines Contract Manufacturer (http://en.wikipedia.org/wiki/Contract_manufacturing) as -

A contract manufacturer ("CM") is a firm that manufactures components or products for another "hiring" firm. Many industries utilize this process, especially the aerospace, defense, computer, semiconductor, energy, medical, food manufacturing, personal care, and automotive fields. Some types of contract manufacturing include CNC machining, complex assembly, aluminum die casting, grinding, broaching, gears, and forging.

In a contract manufacturing business model, the hiring firm - typically an OEM - approaches the contract manufacturer with a design or formula. The contract manufacturer will quote the parts based on processes, labor, tooling, and material costs. Typically an OEM will request quotes from multiple CMs. After the bidding process is complete, the hiring firm will select a source, and then, for the agreed-upon price, the CM acts as the hiring firm's factory, producing and shipping units of the design on behalf of the hiring firm.

Many well-known companies use contract manufacturing as an alternative to operating and maintaining their own factories. Contract manufacturing can be used for anything from single components to a complete product. Printers, computers, and cellular phones personal care products are all examples of products that are made using this method.

In an international context, establishing a foreign subsidiary as a contract manufacturer can have favorable tax benefits for the parent company, allowing them to reduce overall tax liabilities and increase profits, depending upon the activities of the contract manufacturer.

Thus you may notice that this a vast area and if you could narrow down your inetrest area, you would get very directed responses. :)

It is about your extension of the quality management system to a place where he does exactly per your specifications. The capability and competency of the supplier to understand and bring to effect all techincal, commercial and regulatory requirements related to the process he is given to execute needs to be assessed. This is first in the evaluation and selection of source and later about monitoring supplies. Technical audits, management system audits, Assessment of infrastructure and maintenance of facilities, HR capability and training of his human resources could be typically considered along with sample evaluation, process capability and validation, and maintenance of records of supplies.
Does this guide you forward ...... ?
good luck

Thank you for the guidance. I have an experience in a manufacturing company before and have been audited , but have never been in the field of Contract manufacturing ( where you need to select the manufacturer for you)and that is why I am looking for guidence and information so that I can be prepared for the task.
As per your guidance it is like auditing the company and monitoring excatly the same was we do for our company.
Is there a paper or articel related by any chance as ISO 13485 or 9001 hardly talks about it .

One of the best ways to control the subcontract of the manufacturing of your design is to create a written agreement with your supplier

The agreement would include issues such as:

1. Quality system requirements and notications of changes to the system
2. Right of access
3. Traceability requirements
4. Notification of nonconforming product
5. Changes to processes

As part of your internal audit, you may want to schedule an audit at the supplier on a periodic basis to ensure that they are following the requirements.

Thank you so much for your answer to my questions. Are there any samples that I can see which could make it easier. Or any link where Ic an read more about this.:thanx: