This is my first post to the Cove forums. Stumbled across them last week and have been hooked ever since!

My question is centered on Part 820 consulting. I am the CEO of a new medical device company that is in search of a consultant in the Charlotte, NC area. We manufacture a product that is not regulated by the FDA; however, one of the large device companies that we are negotiating with on becoming a supplier is requiring that we are Part 820 compliant. We have <10 employees and have a current QMS based on 13485. We also manufacture (or will) two implants that we must submit 510(k)s for. The 13485 basis for our QMS is justified by our future need of 13485 since we intend to market to Canada and South America.

Having said all that, here is what we need:
Gap analysis - current QMS and Part 820
2 510(K)s - plenty of predicate devices for substantial equiv.
13485
CMDCAS
perhahps CE

A lot of work. My problem is that based on our initial experience with consultants, I may as well throw a dart at the wall. There seems to be no standard "range" for consulting fees. I am not adverse to paying someone for quality services but when I get quotes for a single 510(K) ranging from $8000 - $225,000 and everything between and $4,000 for a gap analysis, it makes me a little cautious.

I would greatly appreciate any guidance from this audience as to realistic financial expectations for the services listed above. Eventually, we plan to hire someone to manage regulatory issues - it is just not possible at the current time.

Thanks in advance!

This is my first post to the Cove forums. Stumbled across them last week and have been hooked ever since!

My question is centered on Part 820 consulting. I am the CEO of a new medical device company that is in search of a consultant in the Charlotte, NC area. We manufacture a product that is not regulated by the FDA; however, one of the large device companies that we are negotiating with on becoming a supplier is requiring that we are Part 820 compliant. We have <10 employees and have a current QMS based on 13485. We also manufacture (or will) two implants that we must submit 510(k)s for. The 13485 basis for our QMS is justified by our future need of 13485 since we intend to market to Canada and South America.

Having said all that, here is what we need:
Gap analysis - current QMS and Part 820
2 510(K)s - plenty of predicate devices for substantial equiv.
13485
CMDCAS
perhahps CE

A lot of work. My problem is that based on our initial experience with consultants, I may as well throw a dart at the wall. There seems to be no standard "range" for consulting fees. I am not adverse to paying someone for quality services but when I get quotes for a single 510(K) ranging from $8000 - $225,000 and everything between and $4,000 for a gap analysis, it makes me a little cautious.

I would greatly appreciate any guidance from this audience as to realistic financial expectations for the services listed above. Eventually, we plan to hire someone to manage regulatory issues - it is just not possible at the current time.

Thanks in advance!


Welcome to the Cove anatomics, and a very good post for your first.

I am not an Subject Matter Expert in the 13485, but I am sure, with this kind of information, you will surely get responses. There are numerous Consultants (I am not one of them) that visit here a lot; and I am sure they will provide some insight to your question.


Added: Once you have determined the choice of Consultants, my advice is to interview them just as if you were going to hire as a Full-time position. Take into consideration, their fit within the Organization, the philosophies of Quality Management Systems (ISO13485). and of course their skills and knowledge. Ask for references and verify them. I am sure you already know this, but I just thought to bring this to the table.

Welcome to the cove.

Who manages your ISO 13485 CMDCAS system now?
I made a table comparing 13485 and 21 CFR 820. However thanks to Google these comparisons are all over the place. Start there for to look for your gaps.

I have had bad experiences with consultant and as a consultant. However for your purposes they should have a RAPS certification and an compatible personality.

So I am a big fan of DIY. For some of your purposes, is there a College that trains industrial Engineers?


If you have not done so, start with http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm.
This helps to find the classification of your implant, what you want is product code, device class, and regulation number.
The product code will direct you to review panel, if Third Party Review is acceptable, submission type, and the most important the Guidance Document for your device.
The guidance document tells you what unique information needs to be included in your submission above and beyond the standard submission.

The FDA and Health Canadaq wbsites have a wealth of information and help to comply with their regulations.

ISO 14971 should also be on your reading list.

At least try starting your submission yourself. If anything else, it feeds the author inside as you create a book that may make a difference.

Good luck with your endeavor.

Hi Anatomics,

I have been consulting within Regulatory Affairs in the Medical Device arena for a number of years. I wanted to respond with a welcome to the boards, and a couple of tips.

First, do a little internet research, places like LinkedIn.com and others have a number of profiles for consultants; and many of these profiles allow for comments and recommendations.

DONT base your decision on cost or certifications, base it on demonstrated experience in the field, knowledge of your product area, experience with micro companies, and personality fit.

Spend some time on the phone talking to them, get to know them, understand their philosphy within RA. Interview them, ask many questions.

Lastly, get quotes based on hourly and per project rates. Ask for a breakdown of activities included in the quote, ask about interface with the FDA reviewer, how will FDA questions be treated, etc.

I'm not a consultant, but:

The $8000 quote must have come from someone that understood your products to be relatively simple and straightforward low-risk Class IIs with obvious predicates that have good safety records, made from materials for which biocompatibility already is established, and most of the other ducks already pretty much in a row.

The $225,000 quote, OTOH, must have come from someone that thinks for some reason that (1) your products are Class III, or (2) they are novel and may involve a multi-step filing process and medical evaluation at the FDA end to determine their regulatory path, or (3) even though they're Class II, they involve big-time risk, complicated biocompatibility issues, or some other situation that will require extensive regulatory management.

Is there any substantive basis for that difference in understanding of the nature of the products?

I would say since you are < 10 employees organization, hire an expert Regulatory Affairs and Systems guy who can help you with these things.

A consultant may be one off exercise, but this new Reg guy will be helpful throughout - isnt it ?

Just my :2cents:

Thanks to all for your comments. I would love to have an in-house regulatory person but as a startup, a seasoned veteran is out of the question. Any idea what someone with <2 years experience would demand?

My immediate goal is 820 compliance and for now we are using the DYI approach. Thanks to the matrix docs on the Cove and the web, I have done a gap analysis and am working to fill the holes. I would still like to have a professional review and will likely look for a local consultant.

Honestly, a person with less than two years experience will not have the breadth or depth of knowledge you require as a start-up, and potentially will cost you much more $$ than a more experienced person. (what will a delay in your 510(k) cost you in terms of 90+ days of lost sales?)

As a general rule of thumb, and it mostly depends on where you are with bringing products to market, I have seen the first permanent RA/QA person brought in around #15, a second person around 30 emp, and another 2 or 3 at around #50 again based on manufacturing ramp up etc.

DIY with a good consultant to guide and review is a good approach.

This is my first post to the Cove forums. Stumbled across them last week and have been hooked ever since!

My question is centered on Part 820 consulting. I am the CEO of a new medical device company that is in search of a consultant in the Charlotte, NC area. We manufacture a product that is not regulated by the FDA; however, one of the large device companies that we are negotiating with on becoming a supplier is requiring that we are Part 820 compliant. We have <10 employees and have a current QMS based on 13485. We also manufacture (or will) two implants that we must submit 510(k)s for. The 13485 basis for our QMS is justified by our future need of 13485 since we intend to market to Canada and South America.

Having said all that, here is what we need:
Gap analysis - current QMS and Part 820
2 510(K)s - plenty of predicate devices for substantial equiv.
13485
CMDCAS
perhahps CE

A lot of work. My problem is that based on our initial experience with consultants, I may as well throw a dart at the wall. There seems to be no standard "range" for consulting fees. I am not adverse to paying someone for quality services but when I get quotes for a single 510(K) ranging from $8000 - $225,000 and everything between and $4,000 for a gap analysis, it makes me a little cautious.

I would greatly appreciate any guidance from this audience as to realistic financial expectations for the services listed above. Eventually, we plan to hire someone to manage regulatory issues - it is just not possible at the current time.

Thanks in advance!Welcome to the Cove!:bigwave:
Sounds like you have a fair understanding of what you need vis a vis ISO 13485 (Many countries, especially Canada, have adopted the "harmonization" concept of ISO 13485, and have passed legislation which requires ALL medical device manufacturers who want to sell products in Canada to be formally registered to ISO 13485 by a Canadian-approved registrar. They make no exceptions for "grandfathering" and even companies with long histories of selling products in Canada must become registered.) The point being the manufacturer is spared getting separately qualified for EACH country he does business in. The CE mark is relatively simple (depending on the complexity of your product) and probably shouldn't cause you much consternation.

Disclaimer:
I'm a consultant/advisor who does the sort of thing you are looking for, BUT I'm not pitching for your business UNLESS you fit the criteria I set forth in this thread
Wes Bucey offers service as "Strategy Advisor" - Seeking Case Studies for Book (http://elsmar.com/Forums/showthread.php?t=9117)

Based on your post, and the point one of the large device companies that we are negotiating with on becoming a supplier is requiring that we are Part 820 compliant.
[emphasis on requiring is mine],
I'm really curious what there is about the proposed relationship between you and this customer which would require compliance. Who would determine you are, in fact, "compliant?"

Consultant fees:
Frankly, without an on-site visit by the consultant/advisor, I would suspect ANY consultant/advisor who quoted a fee (regardless of the amount) without an in-depth review of your current status and comparison of that to where you want to be.

Regulatory:
Of course, you will want to have someone manage/oversee your regulatory issues, but I don't see that as a full time job at your present size - MANY small companies hire and use part-timers (moonlighters or semi-retired) to perform this function - a lot depends on personal compatibility and the person's availability PLUS his dedication to staying abreast of current regulations. Actually, this regulatory person "may" be able to help you select and settle on a consultant/advisor as well, so you probably should not delay in looking for such a person.

Please keep us updated about how things progress for you. We care about ALL our Cove members and we THRIVE on feedback as to whether our advice is helpful or not.

I'm really curious what there is about the proposed relationship between you and this customer which would require compliance. Who would determine you are, in fact, "compliant?"

Perhaps the customer-company wants Anatomics' company to be a Manufacturer-supplier, per FDA definition, rather than a Contract-Manufacturer-supplier...in which case 21 CFR 820 compliance of course is a prerequisite condition for manufacture of non-exempt devices, and the compliance determination would come in the form of an FDA inspection.

BTW, Anatomics...if it's not already taken care of, you might want to add to your regulatory task-list your FURLS Establishment Registration, Small Business Filing Fee Reduction Qualification (assuming that you qualify), and DRLM Product Listing. Getting your Small Business status before you file for the two 510(k)s will save you upwards of $3200, which is worth the small effort involved.

Perhaps the customer-company wants Anatomics' company to be a Manufacturer-supplier, per FDA definition, rather than a Contract-Manufacturer-supplier...in which case 21 CFR 820 compliance of course is a prerequisite condition for manufacture of non-exempt devices, and the compliance determination would come in the form of an FDA inspection.After a few years here in the Cove, I've learned "ASSUME" usually ends up being broken down into its principal components A$$ - U - ME, with the finger for the first part almost always ending up pointed in my direction.:mg:

BTW, Anatomics...if it's not already taken care of, you might want to add to your regulatory task-list your FURLS Establishment Registration, Small Business Filing Fee Reduction Qualification (assuming that you qualify), and DRLM Product Listing. Getting your Small Business status before you file for the two 510(k)s will save you upwards of $3200, which is worth the small effort involved.This is a GREAT tip! Almost any business with only 10 employees has a big head start on qualifying.

If you update your profile to allow for emails, I can recommend an individual who lives in the carolines that I have worked with in the past to address your compliance to the QSRs.

Jeff

If you update your profile to allow for emails, I can recommend an individual who lives in the carolines that I have worked with in the past to address your compliance to the QSRs.

Jeff

Jeff,

You can use the PM system to send anatomics a PM. That might be the best way to contact anatomics. Just a suggestion.