Resources

All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). Get your first chart for free when you create a RAMS account.

LOG INTO RAMS

Combination products use errors white paper
Combination products: common use errors and design considerations
Combination products, such as injection devices, inhalers, nebulizers, and drug patches, are increasingly being used by laypeople for self-
Read More
Transitioning to Medical Device Single Audit Program (MDSAP) Compliance
As the first year of its operational phase ends, the Medical Device Single Audit Program (MDSAP) is finally gaining traction among medical device
Read More
Cleaning, disinfection, and sterilization of reusable medical devices
Cleaning, disinfecting, and sterilizing medical devices are critical activities for preventing the incidence of healthcare associated infections (
Read More
Regulations for Companion Diagnostics in the US and EU
Are you marketing a companion diagnostics (CDx) product? If so, you already know two things: first, CDx products are powerful tools in precision
Read More
Implementing a Medical Device Post-Market Surveillance Program
How do you make sure your device remains safe and effective once it’s on the market? It’s called medical post-market surveillance (PMS), a system
Read More
Overview of ISO 11135:2014 and Medical Device Sterilization
Does your medical device require sterilization? The new ISO 11135:2014 is becoming more recognized as the international standard for the process
Read More
ISO 10993-1 and Biocompatibility for Medical Devices
Biocompatibility testing: an intimidating, time-consuming, and, at times, very expensive requirement in most major medical device markets.
Read More
Medical Device Risk Management in the New Regulatory Environment
The regulatory landscape is evolving: medical device regulators are expecting more mature risk management systems and processes. Further, recent
Read More
Wearables vs. Regulated Medical Devices under the US FDA
One of the biggest challenges for companies in the general wellness space is understanding how and when their technology might encounter FDA
Read More