Design Control and Review
Learn efficient design and development planning, the use of design review tools to facilitate decision making and documentation, and compliance with FDA-QSR and ISO 13485:2003. Well-organized Design History File documentation and change control do not slow down development, rather, these skills enhance productivity.
Risk Analysis and Risk Management
Integrate design-level hazard analysis into Design Planning, Verification and Validation. Use a risk matrix to best effect. Learn how to leverage ISO 14971:2006 and quality systems to optimize your CAPA program with management audits, trending, reporting, and risk mitigation.
Good Laboratory Practices
Apply Good Laboratory Practices to pivotal pre-clinical studies for medical devices, and understand when these requirements are not necessary. Learn protocol development, selecting the best lab for the task, how to monitor compliance to GLPs (for US and International compliance), and when to bring in your own auditor. Understand sponsor responsibilities.
Paladin Medical Key Services
• Customized training to your procedures.
• Training prioritized to immediate needs.
• Relevant case examples used to test knowledge in group settings.
• Clear documentation of training to meet regulatory requirements.
• Reference materials provided with each course, and ongoing support to ensure training effectiveness.
For specific experience details and project profiles, please see the Paladin Medical Profiles in Success (pdf).
©2008 Paladin Medical, Inc.
Customized Medical Device Training
Paladin Medical, Inc. provides customized training programs. The topics below are a sampling.
Medical Devices 101:
Pre-market Requirements and Quality System Regulations
Understand the impact of differing regulatory strategies. Essential for management and key personnel who are budgeting and planning.
Biomaterials Use in Medical Devices
Gain skills in selecting and qualifying biomaterials. Avoid incorrect assumptions about material testing, prior use, and "FDA approved". Learn how to optimize existing information from literature and suppliers, and to select more cost-effective ISO 10993 and ASTM standards testing.
Clinical Trials
Understand the specific obligations for both non-significant risk studies and IDE trials. Learn about protocol design, ISO standards and US-FDA Bioresearch Monitoring requirements for Good Clinical Practices, sponsor-investigator agreements, study management and budget, study monitoring and auditing.
