Medical Device Consulting

Founded in 2012, QA/RA Consulting Group has provided cost-effective market access solutions to start-up as well as Fortune 500 medical device, combination device, IVD and drug manufacturers to achieve aggressive commercialization goals. 

 

Our medical device consultants have spent their careers focused on the global regulatory and quality requirements related to the design, development, manufacturing, marketing and distribution of medical devices, combination devices, IVDs for more than 225 clients with manufacturing, and distribution operations in over 20 different countries worldwide.

Our consultants have a wide breadth of experience.

 

1. Specializations in various disciplines in engineering and science

2. Prior direct interaction with regulators as quality and regulatory management leaders and management representatives in industry. 

3. Knowledge of the requirements and standards relating to many product types 

4. Regulatory and quality management expertise in various countries and economic regions.

 

We get your team where you want to be:

 

1. Fully understand your needs and goals

2. Develop a plan to achieve the goals

3. Assign the right experts to address those needs

 

This is to craft a tailored solution for you. We are your partners in the development and implementation of timely and effective market access solutions and ongoing maintenance of your business allowing you to stay current and relevant in these markets.