Copyright © 2019 QA/RA Consulting Group, Inc. ​All Rights Reserved

Our success...

is measured by your success.

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3335 Tuscarawas Rd
Beaver, PA 15009

+1 412 418 8066

info@qaraconsultinggroup.com

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Contact us today to learn how QA/RA Consulting Group can assist you.

About QA / RA Consulting Group

 

QA/RA Consulting Group is a leader in regulatory and compliance services, specifically supporting the medical device industry, with headquarters in Pittsburgh, PA. With more than 25 years of industry experience, we provide comprehensive and viable regulatory strategies and solutions to companies of every size from start-up to Fortune 500, around the world.

 

QA/RA Consulting Group is a proud member of the Pittsburgh Technology Council, and the Pennsylvania Biotechnology Association, and a JumpStart partner.

Our Commitment

 

We position our clients for success, through experience, knowledge and guidance. Our mission is to lead your organization forward by providing a strong partnership based on trust, integrity and unmatched client focus.  We will provide experience, knowledge and guidance to meet your global quality and regulatory requirements while incorporating exceptional service, value and a balanced business approach.  Through an extraordinary work ethic and industry best practices, our consultants will consistently exceed your expectations in pursuit of your established goals.

Our Competencies and Expertise

Our consultants are industry experts in a broad spectrum of devices, technologies, and markets. We work directly with you to develop and implement efficient and cost-effective regulatory strategies and submissions; Quality Management Systems implementation, remediation and maintenance; and risk management strategies.

Experience

 

Our team of consultants has an average of twenty-plus years experience working with disposable and electro-mechanical, sterile, imaging, and software medical devices and IVDs.

Knowledge

 

Our industry expert consultants have spent much of their careers working on large OEM and start-up, leading-edge, complex medical device projects.

Guidance

 

Our team can assist organizations of any size by navigating the ever-changing regulatory hurdles that impede time to market.

What We Do

 

We provide regulatory support from regulatory strategy development and submission to surveillance audits and FDA communication.

Our consultants have developed custom Quality Management Systems for a wide range of industries. 

Prepare your organization for an upcoming regulatory inspection by having our consultants perform a thorough audit of your quality system. 

Our industry expert consultants can augment your QA / RA staff, or help you to establish and maintain your quality management system, throughout the certification or FDA inspection process. 

From feasibility to obsolescence, we can provide the guidance and support needed to reduce your time to market. 

Quality

Management

Systems

Design &

Development

QA/RA

Outsourcing

Auditing

Regulatory Affairs

Learn more about our services and how QA/RA Consulting can help you.

Meet Our Core Team

We provide a full-service global network of highly seasoned Regulatory and Quality Professionals with industry experience. All of our consultants have 17+ years industry experience with FDA Class I, II and III sterile disposables, combination products (Device / Drug / Biologic), software, durable equipment, diagnostics, point-of-care, therapeutic, in-vitro devices and others.    

Scott Bednar

Founder and Principal

Christopher Ford

Senior Consultant

Dallas Thomas

Strategic Consultant

Mark Weimer

Technical Writer

Michael Zagorski

Strategic Consultant

 

Contact us to discuss what we can do for you.

 

Join our Team

We can offer you exciting employment opportunities and challenges. We are committed to each individual's success by providing development opportunities to ensure personal career aspirations are met.

 

QA/RA Consulting Group, Inc. is an equal opportunity employer.

For information regarding employment opportunities at our company please submit your resume/CV to Info@qaraconsultinggroup.com.

People are the key to our success. We promote a culture of individual excellence involving pride, desire to succeed, accountability, teamwork, and follow through.