Cloud-based QMS/PLM system - Medical Devices Group

Joe Hage

🔥 Find me at MedicalDevicesGroup.net 🔥

July 2018

< 1 min reading time

I am looking for a cloud-based Quality management system with at minimum Document change management and Design control features.
Any recommendations?

source: https://www.linkedin.com/groups/78665/78665-6422825542688477185

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Posted by Joe Hage

Asked on July 11, 2018 12:00 am

551 views

	Private answer Thanks, Joe Hage! Inderpal Singh: How can I help? Marked as spam Report spam
	Private answer Thanks I will look into greenlight, any others? Marked as spam Report spam
	Private answer Easy one. Ask Jon Speer at https://greenlight.guru/. Marked as spam Report spam
	Private answer Matthew Romey Inderpal: Not that I know of, no. Be forewarned, there are some QMS packages that say they do design controls, but they really don't. At least not within the context of ISO 13485 for medical devices. In other words, the QMS might have a document control aspect (i.e. "design control" lower case) but do not do "Design Controls" per 13485 (User Needs -> Design Inputs -> Design Outputs, etc.). Marked as spam Report spam
	Private answer I would recommend Greenlight Guru Marked as spam Report spam
	Private answer Dr. Dieter Werdier I think we can help. We designed and developed tools to easily generate tailored PMCF systems that automatically adapt and improve all safety data of your devices. Let's check if we can help. Marked as spam Report spam
	Private answer Can't wait to have you learn more about Greenlight Guru next week. Marked as spam Report spam
	Private answer Jason Clegg I'm biased because I'm a vendor, but MasterControl has many many medical device customers using the MasterControl QMS for Design Control and Change Management. Do a search for design control software and you will find Greenlight and MasterControl, both of which can automate these processes. Marked as spam Report spam
	Private answer You could also check out the one used by the FDA, which has a cloud based solution for all QMS needs including training and full life cycle design control process systems = MasterControl Marked as spam Report spam
	Private answer We looked into MasterControl but the implementation would have cost close to a 120’000 USD for 5 concurrent users. Also, the office in Thailand that is responsible for Malaysia wasn’t able to answer most of our questions. Last but not least, their test system was extremely slow. Marked as spam Report spam
	Private answer Arena Solutions (http://bom.com) has a QMS/PLM solution. Inderpal Singh - I can connect you to a colleague there - E:chris@cjhudson.com Marked as spam Report spam
	Private answer We provide a cloud solution from Dassault Systèmes implementing Design Control, Quality, Regulatory as well as CAD integration. Let me know, if you need more information ! philippe@adn.fr Marked as spam Report spam
	Private answer I have been looking for the same for my small/start up clients with modest budgets. http://Xybion.com is expensive. GreenLight Guru and Almond (they are a new subsidiary of GSAP) are some alternatives I have found so far. Marked as spam Report spam
	Private answer Karthik Venkataraman Greenlight.guru, qmswrapper and myqualitycloud ..you may try and pick your best..you will still need some subject matter expertise to successfully comply. Marked as spam Report spam
	Private answer Karthik Venkataraman Greenlight guru, qmswrapper,myqualitycloud - you may try and take your best pick! Marked as spam Report spam
	Private answer https://www.linkedin.com/company/compliancequest This company designed an eqms built on the SF platform! Marked as spam Report spam
	Private answer Mark Proulx, CQA, cSSBB Inderpal Singh contact Jessica.Mcqueen@greenlight.guru. Their platform was built by an industry engineer who helped develop an end-to-end platform that does it all for you. Having seen it in action, it's as close to what I wanted to build myself back when I was thinking about automating these processes. Contact Jessica at +1(317)918-5237. As consultant, I've had both small and medium sized clients pick them up because the platform is so intuitive. Give it a look... Marked as spam Report spam
	Private answer www.makromed.com for QMS Software solutions. CAPA, Audits, Complaints, Process Validation, Software Validation and training. Marked as spam Report spam
	Private answer Another vote for Greenlight.guru. Already compliant, easy to use, great customer service and affordable. Marked as spam Report spam
	Private answer Hello, we offer @PTC cloud QMS/PLM solutions. Marked as spam Report spam
	Private answer Try the Auditgarant from the Johner Institute. It’s a german page, but there are a lot of free informations about medical devices Iso 13485 2016 MDR, MDD, FDA CfR 820.... Marked as spam Report spam
	Private answer Jason Clegg @Juerg Suter, we would be interested in learning more about your experience and listening to any feedback you might have as to how we can help improve our customer experience/service. Would you mind reaching out to us to provide us with your feedback? info@mastercontrol.com. Marked as spam Report spam
	Private answer Wismatix QMS - Bringing Quality to Your Business Wismatix QMS is a cloud based quality management suite and comes with many features like RMA management, Defects and deviations management, Document control, Project Management and much more. You can find more information at our website @ wismatix.com. Don't hesitate to contact me at mlo@wismatix.dk. Regards Michael Lars Olsen Marked as spam Report spam
	Private answer Kieran Fallon Just adding Qualio into the mix - https://www.qualio.com/blog/best-qms-software-pros-and-cons-of-the-5-top Marked as spam Report spam

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