If you are a consultant in FDA and Medical Devices and would like to advertise your availability, please use this thread to post anything you would like to promote your services. I suggest a link to a web site and/or a brief profile - some basic information.

My basic expectation if you do this is that you be a regular, active participant in the forum and that you are helping others here. I will delete any one-shot Nellies who come, post their advertisement and are not active in helping others.

NOTE: Your post count must exceed 100 posts to post in this thread.

Thanks for the opportunity.

Docusys Corporation, located in Montreal, Canada, specializes in ISO 9000, ISO 13485 and AS9100 consulting services.

I have assisted over 6 companies for registration to ISO 13485/88. Additionally I perform audits for the largest ISO 13485 registrar and am registered as an approved lead auditor to CMDCAS ( Health Canada requirements).

My fees are reasonable and I do not charge for telephone inquiries.



Danny

For those who wish to seek an experienced FDA/MDD Technical Adviser (Consultant) operating in ASEAN / Malaysian market, pls. contact Dr. K M Loi thru' email at kmloi@kmloi.com or log into www.kmloi.com

Ask for his CV.

Thanks for the chance to advertise...

I am a statistician with experience in medical device, pharmaceutical and biologics. I help companies with process validation, method validation, sampling plans and design of experiments for qualification and validation.

Steven Walfish
President
slwalfish@comcast.net

Good Day

I am a domestic/international quality/compliance consultant, specializing in FDA auditing and compliance. I have assisted clients in the US and overseas.

For over 21 years, I worked for the FDA as a level II certified international medical device investigator. Currently, I am a contract for hire international medical device consultant.

Attached are my resume + background information while at FDA.

As a side note, I thank Elsmar Cove for not only giving me the opportunity to network, but also to assist others and continue to learn all types of quality issues from my well respected colleagues.

Here is an update:

My 25 year career has been concentrating on US/EU medical device auditing, investigating, compliance, and regulatory (except for maintaining/ monitoring complaints & preparing regulatory submissions). I am not a quality engineer nor have set up process validations, etc. However, I have audited and reconciled hundreds of complaints, MDR's, US/EU regulatory submissions, process validation studies, and design control studies over the years.

I am willing to relocate anywhere worldwide and travel 100% (including internationally).

Recently I have been contracted by consulting companies to conduct regulatory/ compliance/ quality/ QSR/ ISO consultative/ auditing work for various US and UK clients + briefly as a regulatory compliance internal auditor.

Prior to this, I had been working for the FDA over 21 years. As a result of a management change, I and other FDA Detroit District staff (including a medical device manager and a medical device investigator) decided in 2006 that it was time for us to leave the government and pursue work in industry. Personally for me, I also decided it was time for a career change (since many FDA personnel and regulated industries have told me over the years to leave FDA and work in industry and/or become a consultant, as a result of my expertise in the medical device arena). While at FDA, I was a level II certified medical device investigator and have been conducting foreign device inspections for over 10 years. The majority of medical device warning letters noted on the FDA web site for Detroit District were a result of my inspections. Regarding my level II medical device certification, both of my certification audits were at large class II/III orthopedic companies. While I was auditing one of these IN firms, one of the authors of FDA's QSIT book (Georgia Layloff, who is now retired) audited me. She gave me a perfect score (unheard of by her) and was stunned that I knew so much about medical devices. My other certification audit (with another FDA auditor- Gregson Joseph) also noted a perfect score too.

I am looking for work in the medical device compliance/ quality assurance arena.

Sincerely,

George G Calafactor
1310 Harding Avenue
Apartment 2A
Linden, NJ 07036
cell: 201-920-5165

Good Day

I am a domestic/international quality/compliance consultant, specializing in FDA auditing and compliance. I have assisted clients in the US and overseas.

For over 21 years, I worked for the FDA as a level II certified international medical device investigator. Currently, I am a contract for hire international medical device consultant.

Attached are my resume + background information while at FDA.

As a side note, I thank Elsmar Cove for not only giving me the opportunity to network, but also to assist others and continue to learn all types of quality issues from my well respected colleagues.

Here is my updated contact information and resume:

George G. Calafactor

Candlewood Suites
100 Candlewood Drive, Room 108
Morris, Plains, NJ 07950
Cell: (973)-462-4018

Thanks for the opportunity

Alberto Rios, ASQ CQA, CQE, CQMgr, CBA, RAB QMSA

Serving in the Mexico area, located in Juarez Chihuahua

www.pleyades-tecnomedica.com

ISO 13485 / QSR / Risk Management / MDD / CMDR

Consultant and 3rd party contract auditor

e-mail: ing_alberto_rios@hotmail.com

Bilingual: English - Spanish

I have relocated back to the Midwest after finishing projects in New Jersey.

I am able to do any type of quality compliance & quality assurance job. Nothing is too basic or demeaning to me. I am willing to work anywhere and travel 100%- including internationally.

Attached are my revised resume and cover letter.

George G Calafactor
1810 South Brookfield Street
South Bend, IN 46613

cell: 973-462-4018