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.

I had the opportunity to sit down with Jon Speer, Founder & VP of QA/RA at Greenlight Guru to record a podcast to discuss streamlining the MDSAP Marketing Authorization & Facility Registration Process.
If you are not familiar with this topic, you need to hear this.
We discuss:
  • Why your regulatory team may be perceived as a bottleneck and why it is important everyone needs to be on the same page about when the product can be released.
  • The connection between marketing authorization and facility registration required for various countries – United States, European Union, or elsewhere.
  • The need to get organized, get better systems in place, and stay compliant when an auditor comes through your door or when you plan to sell into markets.
  • Why small and large companies need to get organized now (i.e. small companies have too much information to maintain, organize, and track while large companies may have resources but suffer from miscommunication and disjointed processes.)
  • The need to not be complacent and not be afraid to change systems. RIMSYS was created to help regulatory professionals successfully and efficiently handle documentation.
You can hear the podcast below or at the Greenlight Guru blog.

The medical device and in-vitro diagnostic medical device industry are in dire need of a robust, practical and easy to use regulatory information management (RIM) system.  Without a unified and collaborative system, serious consequences to your business can occur, including an increased risk of non-compliance, increased costs as well as a possible significant reduction in a product’s revenue potential.

1. REVENUE IMPACT

Missing registration dates, slow-to-market losses, and long-term, cascading impacts such as loss of customer loyalty have an immediate impact to market capitalization. Moreover, improper release of product due to lack of visibility to regulatory statuses can cause fines and loss of credibility with authorities, which can result in increased scrutiny.

2. REGULATORY COMPLIANCE

Compliant product releases are required in the medical device industry. Automation that creates safeguards to prevent unintentional release of products into markets is a must. Regulators from different markets are working together to identify instances of non-compliance as well as misalignment of information in submissions and other communications. More effective control of the submission, enabled by a unified platform, can lead to a leaner, higher quality submission and a reduced regulatory burden.

3. FASTER TIME TO MARKET

Better planning and tracking in a unified system can monitor process metrics, milestones, and automatically informing submissions plan timelines with actual performance. A unified solution connects planning to execution, allowing improved, real-time process monitoring. Teams can quickly spot constraints and take action, allowing the product to get through your process faster.

4. EFFICIENCY AND COLLABORATION

Regulatory processes touch multiple functional areas. Regulatory functions have been piecing together disparate systems to achieve marginal improvement. This landscape inhibits the accurate and timely transfer of data and disruption in cross-functional workflow.

5. TALENT RETENTION

Employee turnover on regulatory teams is linked to the stress and increases greatly if team members consider processes to be inefficient or wasteful. Being able to perform one’s job efficiently and the perception of being part of a high-performing organization contributes to employee satisfaction and retention.

6. INSURANCE POLICY

Having a fail-safe in place now for when (not if) your top talent leaves prevent the loss of company and product specific tribal knowledge. Retraining a new employee without the subject matter expert can cause delays and wasted time. A unified system keeps all information within the company.