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. Going forward, Paladin Medical can help keep your device listing and company registration up to date, and ensure that you only register with FDA and pay fees when necessary.
For specific experience details and project profiles, please see the Paladin Medical Profiles in Success (pdf).
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, and Australian submissions.
©2008 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. Manufacturers need to understand the differences between the international quality standards and FDA regulations, and how to conform to a single, efficient quality management system.
Sweeping changes to the original Good Manufacturing Practices, now known as Total Quality Systems, have made many FDA quality regulations (QSR) harmonious with ISO 13485:2003 requirements. Wherever possible, we integrate systems to avoid redundant testing and extra costs for CE compliance. Using template quality manual and standard operating procedures, Paladin Medical will help you leap ahead.
