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Our Services

FDA 21 CFR (i.e. CGMP / QSR / Part 820)
Foreign Correspondent
510(k) Submissions
Pre-Assessment / GAP Analysis on 21 CFR Compliance
Assistance with 483 closure
Assistance with warning letter strategies
Consultancy assistance on Quality Systems development
MDR / Corrections & Removals / Recall Assistance

European Union - CE Marking
Authorized European Representation (EC - Rep)
General Medical Devices (MDD)
In-Vitro Diagnostic Devices (IVDD)
EMC/Low Voltage Electrical Safety Services
Technical Construction File / Design Dossier Development
 - Risk Management Compliance to ISO 14971:2000
 - Essential Requirements Compliance to Annex I of Directives
 - Labeling Compliance Assistance to EN 980:2003
 - Vigilance Reporting Assistance
Assistance with Selection of 3rd Party Notified Body (NB)

Canada
CMDCAS Compliance Assistance
CMDR Pre-Assessment Audits
New Device Application / Registration Assistance
MDR Assistance
Assistance with selection of 3rd Party Assessment Body

International Regulatory Compliance
ISO 13485:2003 and/or ISO 9001:2000
 - Pre-Assessment / GAP Analysis Services
 - Quality System Management Consultancy Assistance
 - QA / RA Out-Sourcing tailored to your needs
 - Supplier Audits

Training Services
21 CFR (CGMP, CGLP) General RA Principles
CE Marking Compliance (MDD and/or IVDD)
CMDCAS Canadian Compliance (CMDR)
ISO 13485:2003 Made Simple
ISO 9001:2000 Made Simple
Technical Construction File Development
Design Dossier
Process Approach Mapping Techniques



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