What is ISO 13485?

In this episode of RCA Radio, host Brandon Miller is joined by Jordan Elder, Director of Regulatory Affairs at Regulatory Compliance Associates (RCA) to cover the Medical Device quality standard ISO 13485 and why it is important for the industry.

Listen in as Jordan goes over the background of the ISO standard as well as some useful information companies can use when preparing to implement or update the standard.

He also touches on the current proposed amendments by the FDA. If you would like to submit comments or schedule a meeting with Jordan to discuss these proposed changes, please follow this link to our contact us page to set up a meeting. 

About RCA

RCA provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory, compliance, quality, and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.