Kai Harrekilde-Petersen They way I have seen this interpreted, is that the reviewer must be another person - ie the developer cannot be the reviewer. So if you have two software developers, they can review each others code.
If you only have one, say, electronics engineer, you would then use an engineer from another (but related) field.
The operative point is "Always Four Eyes".

Fabio Fioravanti The requirement is not "really independent", it's "an individual who does not have DIRECT RESPONSIBILITY for the design STAGE BEING REVIEWED". No matter how small the start-up would be, it's unlikely that despite of everyone being involved in the process, everyone really has DIRECT RESPONSIBILITY for each and every DESIGN STAGE, unless it's a one man show, in which case I doubt such startup could ever achieve compliance at all. So I'd suggest the firm to carefully review its org chart, and job profiles and its definition of design stages to identify how different roles and responsibilities can be assigned to different people at different design stages. Perhaps roles and stages may need to be redefined or reorganized to achieve this. Direct responsibility does not mean no involvement in the process, it may instead mean, for example, supervision, procedural compliance consistency checking and decision making .

Start-ups tend to outsource manufacturing and other aspects of their business. I find that these type of suppliers make great independent reviewers. Certain suppliers are already covered by an existing NDA and often they want to be involved in the early stages of design to make their life easier down the road. Of course, this assumes that suppliers have been selected sufficiently early in the development process.

Mark Proulx, CQA, cSSBB Orly Shenkar this is an interesting topic for discussion. It's not the first time I've seen something like this posted. Here in the USA, the FDA is very clear about this, although many try to muddy the waters. Having been in start ups AND consulting roles for audits, I get where you're coming from. Bottom line is Fabio is 100% correct. The reason you have a QA department (medical device/pharma) is to have that independent function NOT reporting directly to the design group or manufacturing. This way the group you already have is the very group who is supposed to be qualified to perform design reviews, internal audits and put processes in place that fall in line with both quality regulations and internal policy. They must be "independent" in that they cannot have that conflict of interest with both approving designs and reporting to design management.

Thomas Marmor I agrre wit the other. Independent means that another Person than the creator/author should Review the work. The only requirement is that the reviewer is an expert and has the Knowledge to Review. Ideally the different roles would be defined at the beginning of the development prject. i.e. in a Validation Master Plan.

Andrew Kyle Exposure to the FDA submission processes and documentation for design reviews is quite important. Often, internal resources are not trained in the red flags - action items that have not been addressed and documented for instance. I have written many guidance documents that are available on my profile. Please contact me if you have needs for a detailed review of critical design history documents prior to a 510(k) submission. Your initial submission may set the stage for success or failure based on how well you have screened your documents for needless errors.

PRAKASH RANA Include ISO 14971 Risk Management team in your design. it serve as design review.

There are some really good comments and ideas here. Just don't loose sight of the purpose of the review: to identify flaws, oversights and adequacy to the associated requirements. A knowledgeable independent reviewer can make a huge difference.

Mark Proulx, CQA, cSSBB Orly Shenkar Per the QSR: 21 CFR 820.3(t) "Quality Audit means a systematic, independent examination of a manufacturer's quality system..." Taken in conjunction with 21 CFR 820.22 "Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Also, 21 CFR 820.25 (a) General - "Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.

Mark Proulx, CQA, cSSBB The FDA interpretation of all this is that the Quality Unit responsible for performing ANY audits are to be an independent function, meaning not reporting directly to the department being audited so they can be more objective. They also mean to say that not having enough people to do the job is NOT an excuse. You are required to have the appropriate number of employees to do the job OR you must get an external source to perform the functions and tasks required. Something quite challenging for small startups, but required just the same.

Ed D. Your comment is right on the mark, Mark! Creative and disciplined people are very rare, but they do exist.

If you can not afford a full time person find a retired persons who will work part time. The long term benefit of a full time independent person are $10 saved for every $1 spent. But egos get in the way of excellence. There is a great book "In Search of Excellence" Buy a used copy and read it.

Fabio Fioravanti Just a note to make sure the discussion or certain comments do not deviate from the original topic, which was DESIGN REVIEW. This refers to 21 CFR 820.30(e), so in my view it has little or nothing to do with Quality Audits and section 820.22. Design Review DOES NOT require auditors, as design review is not an audit, and therefore it doesn't even require that the review is carried out by the quality department. On the contrary, I would personally consider much more robust and credible, a process where design review is carried out by product development, R/D or other independent reviewers with specific design skills (independent meaning "with no direct responsibilities at that stage of the design being reviewed"). That said, Mark pointed out in any case a good reference to 21 CFR 820.25, because for avoidance of doubt, this is exactly where the FDA is sending the message: no excuses, you need adequate resources to comply with all activities in part 820, thus including Design Review.

Nancy Knettell, MSMgmt I agree with Fabiano Fioravanti. A Design Review is a review of the technical design as delineated by the designer for technical adequacy. It could be by someone who may have been part of the original design but not the author responsible for the design. Or it could be by another function such as Systems Engineering. For example in Software, there may be 2 software modules that interact. The designer of Software Module 1 may participate in the design of Software Module 2 simply because they may have to interface with one another. But the designer of Software Module 1 is not the designer of Software Module 2. Software Module 1 designer does understand the technology and is able to review effectively the design of Software Module 2. And vice versa. This is meets the intent of Independent Design reviewer with regards to adequacy of the design.