First and foremost, we hope everyone has a safe and healthy New Year!
2018 was a great year at RIMSYS and 2019 is starting off just as strong.
We are excited to announce that we have teamed up with Right Submission, LLC to release a regulatory insight content series catered specifically to the medical device industry. Combining decades of regulatory expertise and behind-the-scenes knowledge, this new partnership will provide unparalleled value to its current and future customer base which includes thousands of regulatory affairs professionals. You can check out our full press release here and our first content piece here: 2018: A Year of FDA Regulatory Changes to the 510(k) Process and Why it Matters to You.
If you haven’t heard of Right Submission, you are in for a treat. Right Submission is a software solution provider specifically catered to the medical device industry (just like RIMSYS) and has developed a SaaS-based tool that creates high quality 510(k) applications ready for submission while meeting FDA’s technical and style requirements. It utilizes a guided process reducing resource requirements, cost, and time, strengthening the content of your submission and streamlining workflows. They also have other tools to help with your Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and researching the correct regulatory pathway. You can check out all of their products here.