Phone:

520.665.9081

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©2018 by MBC & Affiliates, Inc.

Our Consulting Services

Expert Guidance

Consulting

With years of experience, our staff has the capabilities and expertise to take your business to the next level. At MBCA, we combine our insights and skills to transform your quality system into a high performing network focused on excellence and efficiency. We’re proud to help shape and improve how our clients manage their compliance risks and, in turn, achieve their business goals efficiently and effectively.

Regulatory Compliance

Have you received one or more significant observations on an FDA Form 483 or from another regulatory authority?

Let us help you analyze the situation, prepare an adequate response that will not be rejected, and guide your remediation project to ensure optimal implementation and future risk mitigation.  We help take care of you so you can take care of your customers.  Contact us for a free 30 minute consult!

 

Does your organization need to practice managing an FDA Inspection or other regulatory authority audit?  Are you ready?

We can give you a realistic assessment of how you would perform by conducting a Mock FDA inspection or Mock Notified Body audit.  We can also provide complete MDSAP or EU MDR assessments.  Your organization's audit readiness is a critical component of successfully managing your overall compliance risk.  Don't leave it to chance ... contact us today.

 

Have you been given a Warning Letter, Untitled Letter, or other formal regulatory action?

Contact us right away.  We can quickly assess the situation and formulate an actionable plan.  Then, we help you handle the communication with the regulatory agency and provide hands-on assistance every step of the way. 

Quality Management System Support

We provide innovative quality management system solutions that improve performance, eliminate inefficiencies, and increase compliance.  We have a lean and practical approach that streamlines your compliance activities to what is necessary but also meaningful to your business.  Whether you need to re-engineer one section of your quality management system or need a complete reset, let us show you how to maximize your investment to ensure long-term success.  

Are you a new Medical Device or IVD manufacturer in need of your first quality management system?

Get in touch today and allow us to show you our cost-effective and proven solutions for small businesses.

 

Are you a large Medical Device or IVD manufacturer with a global footprint and wondering how all the global regulatory changes will affect your business and your quality system?

Reach out for a free 30 minute consult to see if we are the right fit for you.  It's 100% risk-free!

Get Your Product to Market

MBCA provides comprehensive regulatory and clinical consulting services for small companies and startups attempting to get their medical device through the regulatory process.

We have the real-world experience and expertise to determine what class your device fits into, what type of regulatory submissions are required, what predicate devices are most appropriate, what clinical data is needed to get you to market, and how much time and money it will cost you before you can start making a profit.

 

No matter what phase you’re in, MBCA can provide direction and hands-on support to help you.  Below are a sampling of the services we offer:

Develop a regulatory road map

A clear path through the regulatory maze.  We provide documentation and testing requirements as well as risk assessments. Our experience with the full range of device risks (low to high) facilitates being able to anticipate what the FDA will be looking for.

 

Identify Design Control deliverables

We will ensure that any Design Control deliverables required by the FDA are completed before you file your submission.

 

Write and deliver your submission to the FDA

We do all the technical writing and thoroughly review the completed submission to make sure everything is in order before sending it to the FDA.

 

Secure FDA market clearance/approval for your device

We will defend your submission during the review process with the FDA and assist with securing market clearance or approval for your device.

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