Modern Medical Device QA/RA Services
Are you looking to bring your medical device to new markets? We can help you build and maintain a quality management system that meets the rigorous regulations in those markets.
Hire Us For
Regulatory Advice
Preparation of regulatory strategies for commercialization and technical file preparation to meet regulatory.
Quality Management System
Establishment of the documented quality management system (QMS) to ISO 13485 and 21 CFR 820.
Audits
Executing internal quality audits or supplier quality audits, as well as, conducting gap analysis.
About Us
We are experts who are trained and experienced in all aspects of quality assurance and regulatory affairs in the medical device industry.
Mission.
Our mission is to provide innovative medical device manufacturers with regulatory and quality assistance to address pressing quality challenges.
Why Choose Us?
We know a thing or two about QA/RA… We have the expertise and knowledge to offer impartial advice and services at an honest price.
Whether you’re looking for guidance on compliance with 21 CFR 820, ISO 13485 or 9001, or EU MDR, implementation of Quality Management Systems, or auditing services, we can help.
Have a product to get on the market?
We can help you bring your medical device products to the market. Let’s talk about how we can assist you.
