MDI Consultants, Inc. - A Medical Device Consulting, U.S. Agent, CE mark, ISO, Pharmaceutical  and Quality Assurance, Regulatory Consulting company and Authorized Agent, 510(k) submission assistance, FDA Trouble Shooting, 483 & Warning Letter Responses, Quality System Compliance.

A Medical Device Consulting, U.S. Agent, CE mark, ISO, Pharmaceutical  and Quality Assurance, Regulatory Consulting company and Authorized Agent
510(k) submission assistance 

FDA Trouble Shooting 

483 & Warning Letter Responses 

Quality System Compliance 
 

On Demand Training Programs for
QSR compliance
CAPA 
Design Control
Click Here To Learn More
Corporate Accounts Welcome
click here for more information
 
 

mdi Consultants Inc. is the leading provider of quality assurance, regulatory compliance and clinical services to the Medical Device, Pharmaceutical and Food industries.
 
mdi is the first in the industry to offer a unique fixed price business model and an innovative performance guarantee. Please contact us for more information on our services and our performance guarantee. 

Please visit the industry section of the website for industry specific offerings. Our monthly newsletter, the Insight Report, and FDA updates are always available on-line. 

Please visit our client testimonials section to see both our video testimonials as well as letters we have received from our clients on the value mdi provides.
MDI Consultants, Inc.
Description:A Medical Device Consulting, U.S. Agent, CE mark, ISO, Pharmaceutical and Quality Assurance, Regulatory Consulting company and Authorized Agent, 510(k) submission assistance, FDA Trouble Shooting, 483 & Warning Letter Responses, Quality System Compliance.

A Medical Device Consulting, U.S. Agent, CE mark, ISO, Pharmaceutical and Quality Assurance, Regulatory Consulting company and Authorized Agent 510(k) submission assistance

FDA Trouble Shooting

483 & Warning Letter Responses

Quality System Compliance

On Demand Training Programs for QSR compliance CAPA Design Control Click Here To Learn More Corporate Accounts Welcome click here for more information

mdi Consultants Inc. is the leading provider of quality assurance, regulatory compliance and clinical services to the Medical Device, Pharmaceutical and Food industries. mdi is the first in the industry to offer a unique fixed price business model and an innovative performance guarantee. Please contact us for more information on our services and our performance guarantee.

Please visit the industry section of the website for industry specific offerings. Our monthly newsletter, the Insight Report, and FDA updates are always available on-line.

Please visit our client testimonials section to see both our video testimonials as well as letters we have received from our clients on the value mdi provides.


MDI Consultants, Inc.
55 Northern Blvd ,
Great Neck, NY, 11021
USA

Phone:
Fax:
1-516-482-0186
Email:

Website: www.mdiconsultants.com


Products and Services: FDA compliance - regulatory strategy development, clinical trial development/ management, cGMP compliance, on-site audits, validation (process, software and sterilization) and 510(k)/PMA/ANDA/NDA submission services

ISO compliance - ISO 9000:2000, ISO 14000, ISO 13485:1997 (EN46001), EN540 and Quality Systems

Crisis Intervention - FDA audit response (483), warning letters, and product recalls

Health Canada compliance - medical device licensing, establishment licensing, private label licensing, label review, quality system ISO 13485 certification by CMDCAS recognized registrars

European compliance - CE mark, Medical Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD), and Active Implantable Medical Device Directive (AIMDD)

Electronic drug listing and registration, FDA drug listing and registration, electronic listing and registration"

Other industry-related services - HACCP, In-Vitro Diagnostic Research and Development, U.S. Agent (for non-U.S. companies), sales force performance improvement, and marketing assistance


Experience: **Important Note: This information has been provided by the Company and has not been confirmed by Contract Laboratory Inc. It is recommended that you confirm all information prior to using this Company .FDA compliance - regulatory strategy development, clinical trial development/ management, cGMP compliance, on-site audits, validation (process, software and sterilization) and 510(k)/PMA/ANDA/NDA submission services

ISO compliance - ISO 9000:2000, ISO 14000, ISO 13485:1997 (EN46001), EN540 and Quality Systems

Crisis Intervention - FDA audit response (483), warning letters, and product recalls

European compliance - CE mark, Medical Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD), and Active Implantable Medical Device Directive (AIMDD)

Other industry-related services - HACCP, In-Vitro Diagnostic Research and Development, U.S. Agent (for non-U.S. companies), sales force performance improvement, and marketing assistance


Featured Products and Services

MDI Consultants, Inc. - FDA compliance - regulatory strategy development, clinical trial development/ management, cGMP compliance, on-site audits, validation (process, software and sterilization) and 510(k)/PMA/ANDA/NDA submission services 

ISO compliance - ISO 9000:2000, ISO 14000, ISO 13485:1997 (EN46001), EN540 and Quality Systems

Crisis Intervention - FDA audit response (483), warning letters, and product recalls

Health Canada compliance - medical device licensing, establishment licensing, private label licensing, label review, quality system ISO 13485 certification by CMDCAS recognized registrars 

European compliance - CE mark, Medical Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD), and Active Implantable Medical Device Directive (AIMDD)

Electronic drug listing and registration, FDA drug listing and registration, electronic listing and registration

The company's principals, Alan P. Schwartz and Dr. Anand Akerkar have carefully selected a group of consultants who have accumulated extensive industry experience dealing with U.S., European and Canadian compliance concerns.
MDI Consultants, Inc. - FDA compliance - regulatory strategy development, clinical trial development/ management, cGMP compliance, on-site audits, validation (process, software and sterilization) and 510(k)/PMA/ANDA/NDA submission services 

ISO compliance - ISO 9000:2000, ISO 14000, ISO 13485:1997 (EN46001), EN540 and Quality Systems

Crisis Intervention - FDA audit response (483), warning letters, and product recalls

Health Canada compliance - medical device licensing, establishment licensing, private label licensing, label review, quality system ISO 13485 certification by CMDCAS recognized registrars 

European compliance - CE mark, Medical Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD), and Active Implantable Medical Device Directive (AIMDD)

Electronic drug listing and registration, FDA drug listing and registration, electronic listing and registration
Our staff has deep knowledge in all FDA compliance issues (e.g. device and pharmaceutical submissions, quality system compliance, clinical trial management) as well as European compliance issues (e.g. ISO 9000, ISO 13485, ISO 14000, CE Mark, MDD, IVDD, AIMDD). The staff includes a number of former FDA officials, ISO lead assessors and industry quality managers.