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
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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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