Noblitt & Rueland FDA & International Consulting and Training Services Home Consulting Training: Virtual & On-site Group About US Contact 1 2 3 Our experience working with FDA / ISO / International compliance & regulatory issues allows us to help our clients meet their regulatory challenges. Quality systems, submissions, technical, audits, etc. Consulting services can be done remotely or on-site as the situation allows. Virtual & On-site Training Course (Virtual & On-site Training Course List) We can provide companywide, department or project team training to expedite your project to completion and in compliance with regulatory requirements. Prepare before your next FDA Inspection or Notified Body audit. See our list of one day courses. Courses can be customized to meet your specific needs. Call or email with any questions. Clients find on-site or virtual private training to be very beneficial and cost effective for their teams. Courses can be taught specific or customized to the company, products, and processes. 510(k) Submissions CE Mark Technical Files /Dossier PMA, IDE, De Novo, etc. Internal Audits, Vendor audits, Mock FDA Inspections Compliance to FDA regulations and international standards can be confusing and delay schedules if done improperly. Non-compliance can result in much worse problems and ugly situations. FDA inspections and Notified Body audits are rigorous, but can be completed successfully with training and knowledgeable preparation by your team. Noblitt & Rueland offers training and consulting services to help your company to gain and maintain compliance. Our consultants and trainers are experts in medical device regulatory requirements having years of experience helping medical device manufacturers. This website provides details on regulatory training courses available and numerous consulting services to help you succeed. Contact us or submit a request for proposal to see how we can to assist you. Virtual or On-site Training Courses: Design Control and Risk Management Accelerate your project schedule with ‘Design Control Compliance for FDA & ISO’ and ‘Risk Management & ISO 14971’ training for your project team to get everyone working together with a common understanding. Noblitt & Rueland has over 25 years of experience helping Medical Device manufacturers with FDA & International Regulatory and Compliance issues. From Consulting services by experts to training well over 4000 medical device employees we have the expertise & knowledge to get the job done right. Free Pocket Reference. Always have 21 CFR 820 handy. Convenient size to carry. Volume purchases available. Just one of our many services, our Software Quality Assurance consulting has benefited many clients by either helping to implement a FDA & ISO compliant Software Quality Assurance program/process or by assessing their current system for improvements. Having a system that seamlessly fits into your overall Design Control process or Quality System can improve overall compliance and efficiency.. Over 25 years of hands-on experience working with FDA & ISO/International issues. Expert consultants and trainers including former FDA staff. Clients worldwide. Contact Us About Us Consulting Opportunities Training: Virtual & On-site Consulting Services Home Contact us at: info@noblitt-rueland.com Copyright © 2021 Noblitt & Rueland