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Please use this form to request more information, or to have someone from MDRA contact you.  Thank you!

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  Please check all items that apply to the needs of your company.

Help with FDA

Help with CE Mark

Validation Studies

Have CE Mark and want to enter      US Market.

Need help obtaining CE Mark

Product and Process Validation      Studies

Regulatory Strategic Plans

International Regulatory       Strategic Plans

Software Verification and      Validation

Product Classification      Assessment

Product Classification       Determination Assistance

Sterilization Validation

510(k) Pre-Market Notifications

Pre-assessment and Gap       Analysis Audits

Validation Master Plans

Clinical Studies

Preparation of Declarations of       Conformity

Protocol Preparation

Establishment Registration

Preparation of Essential      Requirements

Validation Report Preparation

Product Listings

Preparation of Technical Files

Data Reduction and Statistical      Analysis

Need US Agent

Quality Systems

US Distributor Information

Quality System Regulation (QSR) Compliance Audits

Additional Services

Quality Manual and Procedure Preparation

Translation Services

Quality System Improvement Programs

Company Training

Independent Supplier Approval Audits

Request newsletter

Design Controls Program Assistance

Speakers Bureau and Training      Presentations

Product Risk Analysis

MEDICA

Would like to s chedule an appointment to meet with an MDRA representative during MEDICA.

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