Noblitt & Rueland
Consulting
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.
- Submission Preparation (inc. 510(k), CE Mark, De Novo, IDE, etc.)
- Internal Audits, Vendor audits, MDSAP Preparation
- Mock FDA Inspections
- IEC 60601 Consulting
Training
On-site & Virtual Training Courses (On-site & Virtual 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.
more infoOn-site or Virtual Training
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.
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Regulatory Compliance Services for Successful Companies and Projects
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.
more infoTraining / Course Highlights
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On-site or Virtual 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.
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On-site or Virtual Training Courses:
Software Compliance, V&V and IEC 60601
‘Software compliance’, including ‘Software V&V’ during development can delay a project and result in submission rejections. Train your team how to achieve compliance without slipping milestones. Plan early for ‘IEC 60601’ certification requirements to prevent costly re-design and delays.
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On-site or Virtual Training Courses:
Quality System Regulation & ISO 13485:2016
Prepare for your FDA or ISO inspection/audit by training your company on the ‘FDA Quality System regulation (21 CFR Part 820)’ and/or ‘ISO 13485:2016’. Consider training your own ‘Auditing’ team to perform internal audits.
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On-site or Virtual Training Courses:
Complaint Handling & MDRs, Process Validation
‘Complaint Handling, MDRs, CAPA’, and ‘Process Validation’ are very high on FDA's list of Warning Letter citations every year. These are areas you can expect FDA and Notified Bodies to audit closely.
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On-site or Virtual Training Courses:
510(k) and CE Marking (New MDR & IVDR)
‘510(k) submissions’ & ‘CE Marking’ is the lifeblood of most medical device companies. We will be teaching how to create and submit a 510(k) submission package and how to CE Mark your devices.
About us
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.
more infoServices Spotlight: Software Quality Assurance
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..