Medical Device Quality, Regulatory, and Compliance

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About QA/RA Consulting Group

QA/RA Consulting Group is a leader in medical device quality, regulatory, and compliance services. QA/RA is headquartered in one of the world's fastest growing hubs for the medical device industry: Pittsburgh, Pennsylvania. With more than 25 years of industry experience, we provide comprehensive and viable regulatory strategies and solutions to companies of every size around the world, from start-up to Fortune 500.

 

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

Our Commitment

We position our clients for success with top-notch experience and knowledge and an enterprising culture that enables us to provide guidance in accord with the latest standards and regulations. 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.

Experienced

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

Knowledgeable

Our industry experts have spent much of their careers working on large OEM, start-up, leading-edge, and complex medical device projects in a variety of device types.

Enterprising

Our team is trained in the latest standards and equipped to assist organizations of any size in overcoming the ever-changing regulatory hurdles that impede time to market.

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.

What We Do

Regulatory Affairs

Quality

Management

Systems

Auditing

QA/RA

Outsourcing

Design &

Development

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