Thanks, Joe Hage! Inderpal Singh: How can I help?

Thanks I will look into greenlight, any others?

Easy one. Ask Jon Speer at https://greenlight.guru/.

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.).

I would recommend Greenlight Guru

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.

Can't wait to have you learn more about Greenlight Guru next week.

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.

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

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.

Arena Solutions (http://bom.com) has a QMS/PLM solution. Inderpal Singh - I can connect you to a colleague there - E:chris@cjhudson.com

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

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.

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.

Karthik Venkataraman Greenlight guru, qmswrapper,myqualitycloud - you may try and take your best pick!

https://www.linkedin.com/company/compliancequest

This company designed an eqms built on the SF platform!

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...

www.makromed.com for QMS Software solutions. CAPA, Audits, Complaints, Process Validation, Software Validation and training.

Another vote for Greenlight.guru. Already compliant, easy to use, great customer service and affordable.

Hello, we offer @PTC cloud QMS/PLM solutions.

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....

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.

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

Kieran Fallon

Just adding Qualio into the mix - https://www.qualio.com/blog/best-qms-software-pros-and-cons-of-the-5-top