Click to learn about the in vitro diagnostic (IVD) regulatory compliance challenges for Medical Device firms marketing product to the…
Learn from RCA's compliance consultants about important lessons learned from medical device quality investigations & product failures.
Understanding the similarities and differences between ISO 13485:2016 and CFR 21 Part 820 is a key step toward creating and/or…
Click to learn about how RCA assists current and new clients with MDR consulting & implementation of the updated EU…
Read RCA’s handout outlining the fundamental elements of a Design History File (DHF) and its role in the evolving regulatory…
Click to learn more about RCA's Medical Device Single Audit Program (MDSAP) & our medical device consultants who audit a…
Click to learn about RCA's MDR consultant solutions for the medical device industry for new Compliance and MDR Implementation Services.
Whether struggling with a submission strategy and execution or dealing with regulatory compliance, RCA stands ready to support your medical…