In Vitro Diagnostics Suppliers Directory Index

Kamm and Associates

P.O. Box 7007
Deerfield, IL 60015
Tel: 847/374-1727
Fax: 847/374-1728

Web: http://www.fda-consultant.com
E-mail: dkamm@fda-consultant.com

• We help firms worldwide get their medical devices and in-vitro diagnostics into the US and European markets with programs that work effectively with FDA and European MDD/IVD requirements.
• FDA Submissions: 510(K), PMA, IDE
• QSR/cGMP Compliance Programs: Auditing, Consulting, Training, Certifications.
• FDA 483 and WARNING LETTER Strategies and Responses.
• Device Development, UL/CSA Approvals.
• Validations: Software, Process, and Product.
• ISO-9001 and CE Marking Preparation
• Cost effective hourly, daily, complete project, or retainer rates.

Call for your free pocket size copy of the Quality System (cGMP) Regulation

KAMM & ASSOCIATES invites you to take advantage of our no-nonsense approach to achieving regulatory compliance. Our internationally experienced staff is ready to assist you. We have a solid core of professional consultants, each having over 25 years of medical device experience, and a network that can build a cohesive team for virtually any project size or skill required.

LETTER FROM A SATISFIED CLIENT: "Thank you for your capable assistance during the FDA inspection. I understand that with your help, the outcome turned out to be a great success. I really appreciate it. ....I should say a lot of the credit goes to you. I'm looking forward to working with you again. Best regards, (President of Company)."

Categories this company is listed under in the In Vitro Diagnostics Suppliers Directory:

• Consulting Services: Quality Systems Certification (53 companies)
• Consulting Services: Regulatory Affairs (73 companies)