Medical Device Quality Assurance Services

Regulatory Compliance Associates quality assurance (QA) consulting services includes quality system assessments, QA strategies and planning, and identification of quality metrics. Our quality consultant services are designed to ensure continuous improvement that supports your business needs & achieves quality goals.


RCA can provide needed expertise and services in the following key areas:

Data Integrity & cGMP Consulting

Maintaining data integrity is an important part in ensuring the manufacturing quality of your medical device. It is crucial in current good manufacturing practices (cGMP), and employees should have the...

Outsourced Quality Support

Interim Management, or outsourced quality and regulatory management, has become an increasingly common practice in the life science industry. The quality assurance (QA) and regulatory affairs (RA) functions create extra...

MDSAP : Medical Device Single Audit Program

Multiple countries are participating in the program including the USA, Australia, Brazil, Canada, and Japan. One item of note is that manufacturers selling products in the Canadian market were initially...

ISO 13485

Whether you are just beginning your journey to certification or you are faced with aggressive timelines to meet the ISO13485 or MDR transition deadlines, RCA’s quality assurance experts can help. 

Connect with RCA Today

Contact us to learn more about our regulatory compliance experts and how they can help


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