Create
cancel
Showing results forΒ 
Search instead forΒ 
Did you mean:Β 
Sign up Log in
Celebration

Earn badges and make progress

You're on your way to the next level! Join the Kudos program to earn points and save your progress.

Deleted user Avatar
Deleted user

Level 1: Seed

25 / 150 points

Next: Root

Avatar

1 badge earned

Collect

Participate in fun challenges

Challenges come and go, but your rewards stay with you. Do more to earn more!

Challenges
Coins

Gift kudos to your peers

What goes around comes around! Share the love by gifting kudos to your peers.

Recognition
Ribbon

Rise up in the ranks

Keep earning points to reach the top of the leaderboard. It resets every quarter so you always have a chance!

Leaderboard

πŸš€ How to Build a Compliant Quality Management System on Confluence Cloud

πŸ’‘ So you had an amazing idea for a revolutionary medical device? Fantastic!

πŸ₯³ You put together a group of talented people who are psyched to develop a life-changing device? Congratulations!

πŸ’° You have an idea of how to sell your innovative product once its on the market? Wonderful, you are almost there!!

πŸ€·β€β™€οΈ Your product meets all the regulatory requirements in markets you are targeting? Wait, what? What requirements?

Let’s start with the fundamentals.

 

A

The very first thing medical device companies should have in place is the content of the Quality Management System.

A Quality Management System describes the setup of the company, its procedures and practices including the detailed description of your product development.

Medical Device Quality Management System in the EU has to comply with the MDR (more detailed requirements in ISO 13485, IEC 62304, ISO 14971) and in the US, it should be compliant with the FDA 21 CFR 820.

 

B

A Quality Management System should be electronic to support collaboration and electronic search for quality system documents.

An electronic Quality Management System should have document approval capabilities which means that approvers should be able to electronically sign documents. Electronic Quality/Document Management System should comply with requirements of FDA 21 CFR 11, 21 CFR 820 and ISO 13485.

 

C

Once you have the content of your Quality Management System and it is all working well on an electronic document management platform, you will need to consider its validation. Software tool validation is yet another requirement for medical device companies - described both in ISO 13485 (clauses 4.1.6 and 7.5.6) as well as in the FDA 21 CFR 820.75 and 21 CFR 11.

With most electronic document management platforms being on Cloud where changes are made often, a manual validation is out of the question. Ideally, validation should be automated for periodic integrity checks of your Quality Management System software providing fully compliant report with documented evidence as a result.

 

Introducing the SoftComply Cloud eQMS Solution on Confluence

 Cloud eQMS Solution with DM small.png

A

SoftComply eQMS Documentation consists of a full set of templates for SOPs and technical documentation with embedded guidance for finalizing it based on your organisation and device. SoftComply eQMS Documentation is based on ISO 13485, IEC 62304, ISO 14971 and FDA 21 CFR 820.

 

B

SoftComply Document Manager is a Confluence Cloud app that is the central hub for managing your documents: it has several compliant document approval workflows out-of-the-box and FDA 21 CFR 11 compliant e-signatures. Join our live demo sessions to check it out.

 

C

SoftComply Validation for Confluence Cloud is an app that runs automated validation tests of your Confluence instance once a week after you have set it up. This is a fully supported service. Join our webinar & live demo to see it in action.

0 comments

Comment

Log in or Sign up to comment
TAGS
AUG Leaders

Atlassian Community Events