Critical Medical Device Compliance Training to be held at Disneyland Resort!
Expert Consultants ready to assist with your compliance needs!
Medical Device Regulatory Submissions cleared quickly!

Welcome

Over 25 years of hands-on experience allows us to help our clients navigate the regulatory and compliance issues faced on a daily basis as well as occasional unwanted surprises encountered.

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.

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Training

10 Courses, July 14-18 at the Disneyland Resort. Important Medical Device compliance topics. Prepare before your next FDA Inspection or Notified Body audit. See our list of one day courses. Take one or more.

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On-site Training

Clients find on-site or in-house, 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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Training Program at Disneyland Resort will cover many critical regulatory topics!

Over a period of 5 days from July 14-18, ten (10) courses will be taught in Southern California on a variety of critical regulatory topics that the U.S. FDA and international regulatory bodies have on their radar during inspections. The subject matter of these courses show up as the top Warning Letter citations and FDA 483 observations after an FDA inspection. Topics range from Quality system compliance (FDA, ISO 13485, Canada), Design Control, Risk Management, Software V&V compliance strategies, Complaint Handling & MDRs, CAPA, Process Validation, Auditing, and Submissions (510(k) and CE Marking). Meet your training requirements and be prepared for your next inspection. Attendees may register for one or more courses. Discounts available.

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Training / Course Highlights

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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.

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Consultant & Trainer Spotlight: Jim Kozick

Now a consultant, Jim worked for FDA for nearly 30 years and was the FDA Los Angeles District Director of Domestic Investigations having 75 investigators reporting up to him.

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