Kyle Rose 0:01
Thanks, everyone. I'm Kyle Rose. I'm CEO and founder of Rook Quality Systems. Rook systems is a medical device consulting firm that provides quality and regulatory support to all types of medical device companies. We have a team of 40 consultants based around the US we also have a branch in Taiwan and a branch in Europe that provides quality regulatory support to our clients all over the world. We have key expertise in software as a medical device diagnostics and monitoring technologies. We do a lot with wearables a lot with remote monitoring devices as well. And we also provide support for all other types of medical devices as well. We have 15 certified auditors on our team, and work with very early stage companies to help implement the quality systems at the right time, make sure it's efficient, and not overcomplicated or over burdensome for their products. With our specific support that we provide, our team provides very hands on consulting support a lot of consultants that are in the industry, provide advice or provide templates and kind of leave the clients to go do the work themselves. Our team is always focused on actually providing the hands on support where we can lead your activities we can lead your design history, file creation, your risk management creation, we can conduct audits for you both internal and external audits. We also support if you're getting audited by the FDA, or audited by your ISO or CE mark auditor. We conduct software validation, including cybersecurity testing for our clients. So cybersecurity has been a hot button topic for all the industry lately. We meet with the FDA regularly with our submissions that are under review, and have a very good idea of what they're looking for as far as current cybersecurity practices, records of testing, risk analysis, all those things within your cybersecurity packet. We also do international regulatory submissions that with our scope of consultants around the world, we provide international regulatory support for CE mark EU MDR, UK, ca mdsap, as well as other regions as well. And then within this scope, we also provide quality system training for our clients. We have been coming to LSI. I think this is our fifth conference in the US. And we've also done all of the international conferences with LSI. So we've got a really good partnership with that. With our success at LSI. We've got some success stories of previous companies that we've met at LSI and help them achieve their quality and regulatory goals. So some of these success stories we had a client who we had met at the time they had a quality manager she was looking to phase out and retire from her existing role. So we took over the quality system, help them implement a QMS helped update their design file their quality system train the team. That company then went through an acquisition process and we helped them transition all their quality system to the acquiring company and support all those audits through the due diligence process. We've also recently helped companies with 510 K submissions, eu MDR transition and technical support for all the technical file and clinical evaluation report, as well as monthly QMS management we have clients that don't have an entire or internal quality team and they actually look to rook to manage their whole quality process for them. So using an E QMS. We're able to manage their entire quality process for these clients without needing an internal quality team, which is really beneficial especially for early stage companies. This is my contact info. We also have two other consultants, Bobby and Molly who are here as well. LSI so if you're looking forward to meeting have any questions about quality or regulatory please reach out to recall the systems
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