About RA/QA International L.L.C.

RA/QA stands for Regulatory Affairs and Quality Assurance. These two terms go hand-in-hand in many organizations, often becoming inseparable within the ultra-competitive and highly regulated industries of Medical Devices, In-Vitro Diagnostics and Healthcare Services.

RA/QA International, L.L.C. is a highly respected consulting organization, serving our medical / in-vitro device manufacturing and healthcare services partners as an efficient resource for international RA/QA compliance strategy, implementation, training and verification.

Mission
Our mission is to supply valuable, cost-effective services in order to:

1) Maximize your success for prompt domestic and international regulatory compliance.

2) Minimize the issues (and time) you may face with the FDA, your Registrar, Notified Body, Competent Authorities, Ministries of Health, etc.

And

3) Optimize the performance of your Quality and Risk Management Systems through effective implementation of ISO 13485, ISO 9001, ISO 14971 and Best Practices within the industry.

Goals
Our values and goals are:

To be fair, honest, and ethical in all that we do.

To remain vigilant and current on changes to medical device and healthcare regulations, and on the potential impact of such changes to our clients.

To maintain a highly reputable competency regarding those regulations.

To determine consistent (yet progressive), comprehensive, customized and optimized approaches to meet our client's challenges.

To share our knowledge and experience with the industry and its regulators in an efficient and cost-effective manner.

Our Members

Martin (Marty) J. Leighton
Formerly Executive Director of Operations and Strategic Business Development for the US Medical Division of TUV Product Service, Inc., Martin is now Principle Member of RA/QA International, L.L.C.

Philip (Phil) A. Smart
Former head of TUV Japan and its Medical Device operations, Phil Smart is a founding member and brings over 20 years of technical expertise and professional experience to RA/QA International.