Technical Construction Files and Essential Requirements Checklist
The rules can be confusing for a US-based company preparing their first Technical Construction File in anticipation of a European market introduction. Paladin Medical will show you how to optimize existing Device Master Records and Design History Files to create an efficient Technical Construction File. An Essential Requirements Checklist ensures that documentation is available for review by the Notified Body you select. For products where you may "self-declare", we serve as an independent eye making sure that your documentation is in order.
Please see the Paladin Medical Profiles in Success (pdf) for specific experience details and project profiles.
Paladin Medical Key Services
• Compliance with Corrective and Preventative Action (CAPA).
• Risk Management programs compliant with ISO 14971:2007.
• Complaint systems, field actions, and Medical Device Reporting.
• Procedures for Management Reviews and internal audits.
• Gap analyses in preparation for FDA inspections and ISO audits.
• Applications to Competent Authority for Class I products.
• Technical Construction Files and Design Dossiers.
• European product requirements for foreign compliance.
• Device listings and company registrations.
• Canadian, European, Australian, Latin American, and Japanese submissions.
©2009 Paladin Medical, Inc.
Regulatory Compliance and Conformity
Total Quality System Implementation (GMP/ISO)
Paladin Medical, Inc. helps clients produce standard operating procedures to ensure compliance and conformity with the least strain on valuable resources. Wherever possible we integrate FDA Quality System Regulations with ISO 13485 to avoid redundancy. Using template quality manual and standard operating procedures, Paladin Medical will help you leap ahead.
Corrective Actions Reporting and Removals
Paladin Medical will help you with your CAPA and recall issues and operating procedures which ensure you make only the necessary MDR and Vigilance report in a timely manner.
