About QA/RA Consulting Group

Medical Device Consultants

You will know what you are getting by hiring QA/RA Consulting Group and you can feel confident that our knowledge and experience has immediate benefits.

Who We Are & What We Do

QA/RA Consulting Group is a leader in medical device, IVD and combination 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 medical device consultants throughout the United States. We consistently have provided comprehensive and audit ready regulatory strategies and solutions to companies of every size around the world, from start-up to Fortune 500.

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

Our Commitment To You

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 medical device consultants will consistently exceed your expectations in pursuit of your established goals.

Why Work With Us?

We are different from most other consulting companies.

  1. All medical device consultants are fluent English speakers and can deliver critical information succinctly and effectively

  2. Frequent Communication and strict accountability to deliver work products on time

  3. Head of the company is aware of project details and will ensure you are continuing to be satisfied with our service. 

 

Experience You Can Trust

We only employ highly experienced professionals:

  1. Our top medical device consultants have a minimum of 20 years’ experience in small to large medical device, combo device and IVD manufacturers and held leadership titles (i.e. director, VP, etc.) working under a variety of regulations:

    • MDSAP-US, Canada, Japan, Australia, Brazil    

    • US: FDA 21CFR 820, 210, 211 and clinical regulations 

    • EU: Medical Device Directive, Medical Device Regulation, In vitro Diagnostic Directive and IVD regulation

    • Canada: Medical Device Regulations SOR /98-282

    • Japan: Japanese Pharmaceutical Affairs Law: Ordinance 169

    • Swiss Medical Device Ordinance

  2. Our medical device consultants hold degrees and specializations in Mechanical, Biomedical, Electrical, Chemical, Materials, Software Engineering or have scientific backgrounds with specializations in Physics, Chemistry, Biology, Biochemistry, Environmental science.

  3. Our staff has experience with many product types such as:

    1. Medical Device: disposables indirect contact, disposables-direct contact, and wearable, implantable, active implantable (software driven or not, and mechanical or electro-mechanical)

    2. Combination Device: Drug delivery systems (sprays, injectables, implants, etc.), Drug coated devices, etc.

    3. In Vitro Diagnostics: DNA/RNA expression kits, antibody/antigen sandwich assays, sensor-based diagnostics, etc.

Our Process

1

Meet

Call or email us to set up an initial meeting.

2

Define

Define the scope of work and timelines needed.

3

Agree

Sign an agreement to deliver the scope of work within terms acceptable to you and to us.