I have to register a company. I was going to register as a "manufacturer", but they develop specifications for a device and then outsource the manufacturing....so, I believe that falls under "specifications developer". My question is, are there different requirements? like GMP?

Where are you registering the company and for what reasons? What is the primary industry (e.g., supply chain serving which final customers ... health care, education, automotive, ...) in which you operate?

Where are you registering the company and for what reasons? What is the primary industry (e.g., supply chain serving which final customers ... health care, education, automotive, ...) in which you operate?I presume we are talking medical device.

Outsourcing any or all of the manufacturing is not a bar to registration as a manufacturer. Is it really outsourcing, or do they "license" the design to other companies?

Yes this is a medical device. This company orginally made good for consumers, but just recently wanted to get into medical devices for both physicians and for consumers(OTC). This is the way the company is set up. They hired my engineering company to design the product..all specifications and all of their manufacturing is outsourced. They are basically a headquarters which does all of the financing and marketing. So, I don't know how I would register them. I thought possibly spec. developer would be most appropriate. And if that is they way to go, then, what kind of requirements would they be subjected to? Like with QS or GMP? If development and manufacturing is not completed by them?

In terms of responsibility, even though they outsource the manufacturing work, they will still be responsible for ensuring that all aspects of the regulation are met; i.e., validation of manufacturing equipment / processes (where applicable), etc. Just like your company will be expected to follow design controls.

In terms of responsibility, even though they outsource the manufacturing work, they will still be responsible for ensuring that all aspects of the regulation are met; i.e., validation of manufacturing equipment / processes (where applicable), etc. Just like your company will be expected to follow design controls.

I agree. For ISO 13485 your company will need to have all processes included. No elements of the design or manufacturing (chapter 7) can be excluded when a company puts a device on the market. The company has the responsibity to control the service suppliers in order to meet with the ISO requirements. See the definition for manufacturer in the ISO standard

With respect to the European MDD you will have the same responsibility.

I agree that the category of "specification developer" fits in terms of FDA registration, if you perform no manufacturing. From FDA website: http://www.fda.gov/cdrh/registration/whomust.html#manufacturer

With regard to GMP/QSR responsibilities, this is from FDA's Device Advice:
"Specification developers provide specifications to contract manufacturers, who produce devices to meet the specifications. The contract manufacturer may package and label the device, or the finished device may be shipped to the specification developer for packaging and labeling.

Specification developers are manufacturers and are subject to the GMP requirements that apply to the activities they conduct, such as various design controls including correct transfer of the design information to a contract manufacturer [21 CFR 820.30 (h)]. This activity, in turn, requires an adequate device master record (21 CFR 820.181) and adequate document change control [21 CFR 820.40 (b)]. Further, if the product carries the specification developer's label, the developer is responsible for maintaining a complaint file and processing complaints, plus maintaining the device specifications and other appropriate documents in the device master record." http://www.fda.gov/cdrh/devadvice/32.html#repackagers_relabelers

-Victoria

Victoria,

I am working with a small medical device company to develop and implement a QMS and procedures that comply with both FDA QSR and ISO 13485. The company is registered as a specification developer and outsources all design and manufacturing activities. In this particular scenario, the company has engaged the services of a design and development outfit that will also manufacture the device.

My question has to do with clause 7.3 of ISO 13485, namely which exclusions can this med device company claim? They provide the specifications/ product requirements (the inputs) and assess the prototype (the output) for usability, performance, etc.

For the purposes of ISO 13485 purposes, my thinking is that the med device company is responsible for: development of specifications/product requirements, labeling, verification the the med device meets specifications/product requirements, validation (the water resistance of the device was validated in an informal experiment), and control of design and development changes (the med device company is just informed and consulted with about changes; the contractor controls all related activities as per the SOPs).

So, how acceptable would it be to identify the exclusions and things the med device company has to do and put these activities in the quality manual and then write procedures for these activities?

I hope this is not too convoluted. Any insight will be much appreciated.

Best regards,

Mark

Mark, from an FDA perspective, if the Contract Manufacturer does not participate in marketing the product, they have very limited responsibility for the individual device in question...even if they're otherwise a registered Establishment, and have other Listed products for which they are a Manufacturer or Contract Manufacturer.

A Contract Manufacturer that does not participate in marketing of a device that it makes, does not List the device in question and does not otherwise report its participation to the FDA. The Specification Developer is responsible for Listing the device, for obtaining regulatory approvals, and (in full or shared) for the entire design, manufacturing and marketing/post-market processes.

Mark,

The company can not make exclusions to ISO 13485 section 7.3 if they are the manufacturer: i.e. they put the product under their name on the market. It makes no difference if the design and/oe manufacture themselves, or if the outsource these activities. They will remain responsible for the design.

In the quality manual they can adress design controls by indicating they outsource these activities. They must have appropiate supplier controls in place to assure that these outsourced activities meet the requirements of ISO 13485. It is inadequate to be merely informed of design changes. The company is the owner of the specifications and therefore they should approve any change to a specification. Mind you, they will be held legally responsible in case of any incident associated with an unsafe product put in the market under their name.

Please read the Guidance on ISO 9001:2000 Sub-clause 1.2 Application (http://isotc.iso.org/livelink/livelink/3554792/1.2Application.doc?func=doc.Fetch&nodeid=3554792) for more details from ISO's Technical Committee no.176 responsible for the ISO 9000 series.

The responsibilities expected by the FDA from a specifications developer do not differ from those mentioned above.

Jan

Melissa,

FDA lumps all specification developers, specification providers, contract manufacturers, etc into the "manufacturer" category, and you are responsible for maintaining a QMS and complying with 21 CFR 803, 806, 820, and the general regulations for anything having to do with FDA.

Per FDA 21 CFR 820 general definitions:

"(o)Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions."

It's frustrating, but you'll get through it!