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.

more info

Training

Just Announced...5 Courses, November 10-14 at the Embassy Suites on the Waterfront, Burlingame, California (San Fran Bay Area). Details to come in the next week. Important Medical Device compliance topics. Prepare before your next FDA Inspection or Notified Body audit. One day courses details to be posted within the next week. Take one or more. Design Control, Risk Management & IOS 14971, Software V&V Strategies for FDA & ISO Compliance, 510(k) Submissions, CE Marking Medical Devices, IVDs, and Implantable Medical Devices.

more info

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.

more info

Training Program at Disneyland Resort will cover many critical regulatory topics! (new program in San Francisco Bay area to be posted soon)

Over a period of 5 days from November 10-14, five (5) courses will be taught in San Francisco Bay area (Burlingame, CA) 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 issues such as Design Control, Risk Management, Software V&V compliance strategies, and critical regulatory topics including 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. Details to be posted in the next week!

more info

Training / Course Highlights

more info

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 info

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.

more info