Medical Device Consulting

Founded in 2012, QA/RA Consulting Group has been delivering cost-effective market access solutions to both start-ups and Fortune 500 companies in the medical device, combination device, IVD, and pharmaceutical sectors. We help our clients achieve ambitious commercialization goals while ensuring they maintain the necessary levels of compliance.

Our team of medical device consultants brings extensive experience in global regulatory and quality requirements, spanning the design, development, manufacturing, marketing, and distribution of medical devices, combination devices, and IVDs. We have supported over 225 clients with manufacturing and distribution operations across 23 countries worldwide.

Our consultants have a wide breadth of experience.

 

• Specializations in various disciplines in engineering and science

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

• Knowledge of the requirements and standards relating to many product types 

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

 

We help your team reach its goals.

 

We take the time to fully understand your needs and goals, ensuring we have a clear picture of your objectives.  Then, we develop a strategic plan to achieve those goals, assigning the right experts to address your specific needs.

This approach enables us to create a customized solution tailored to your company. As your partners, we work closely with you in the development and implementation of efficient market access strategies, while also providing ongoing support to help maintain and evolve your business, ensuring you stay competitive and relevant in these dynamic markets.