Quality Management Systems Development and Implementation: ISO9001:2000, 13485:2003, CE Marking and QSR

Regulatory Consulting for U.S. FDA, Canadian TPD and European MDD Requirements
Preparing and Submitting Regulatory Documents
• Pre-market notifications [510(k)s]
• Pre-market approval (PMA) applications
• Master files
• Reviewing and Developing Instruction Manuals and Other Labeling for FDA Compliance
• Providing Liaison with FDA
• Canadian device license applications as well as CE Marking preparation and application for MDD
• Product classification and essential requirements determination

Regulatory Compliance
• Preparation for FDA inspections and registrar or Notified Body assessments
• Assessment study, implementation and follow-up for Biological Evaluation of Medical Devices and Biomaterials according to ISO 10993 standard and regulatory requirements, testing program, preparation of test house planning, test house shopping & selection, most profitable strategical approach for most economical testing program, providing lieson with the research institutes, CROs, governmental bodies.
• Preparation of EMI & EMC testing program for hardware, firmware and for all electronic products, providing test houses and lieson
• Preparation of projected budget for testing programs
• Evaluation of test results, conclusions and reports, providing strategical approach to submit specific products test results based on the regulatory requirements to asses the safety for their approbation from governmental bodies
• Assessment study and follow-up for Biocompatibility testing program to provide the safety of specific product
• Recall strategies
• Manufacturing and software information for FDA or Canadian submissions
• Technical files & Design Dossier for EC marking


Quality Management Systems Development and Implementation: ISO9001:2000, 13485:2003 and QSR

Independent Third Party Assessments
• Quality system gap assessments
• Compliance audits
• Internal Quality and Supplier Audits to help minimize internal costs and resource requirements
• Corrective and preventive action programs
• Design control, including Risk Management and design verification and validation
• Document control systems
• Software quality assurance
• QSR Implementation as per ISO 9001:2000 and ISO 13485:2003
• Quality Management System Realization
• Documentation Control
• Management Responsibility
• Management Commitment
• Customer Focus
• Quality Policy
• Planning
• Responsibility, Authority and Communication
• Management Review
• Resource Management
• Provision of Resources
• Human Resources
• Infrastructure
• Work Environment
• Product Realization
• Planning of Product Realization
• Customer-Related Processes
• Design & Development
• Purchasing
• Production & Service Provision
• Control of Monitoring & Measuring Devices
• Measurement, Analysis and Improvement
• Monitoring and Measurement
• Control of Non-conforming Product
• Analysis of Data
• Improvement
• Process Validation Program Development and Implementation
• Master validation plans and protocol development as per regulatory requirements
• Data analysis and report generation
• Product Life Cycle