Critical Medical Device Compliance Training to be held on the San Francisco Bay!
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

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

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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 in San Francisco Bay area will cover many critical regulatory topics!

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 frequent 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.

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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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Services 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.

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