MedTech Impuls digital
How to Automate Medical Device Regulatory Compliance


28. October 2021
15:30 - 16:30

**This event will take place in english!**

Location:
digital
 
Registration: Click here to register! 


Topic

Compliance management can be hard and time consuming. It requires coordination within organizations to ensure different functional groups are aligned and that processes meet the regulatory requirements for relevant standards. The cost of non-compliance can be high - appearing in the form of revenue loss, business disruptions, fines, or negative brand perceptions, among others.

Organizations need a compliance program that is built-in, not bolted-on, to their existing workflows and processes. "Traditional compliance practices are incompatible with continuous software delivery processes, leading to slower delivery and unexpected, expensive remediation work." (Gartner®, Hype Cycle™ for Agile and DevOps, 2021, Herschmann, Joachim and Spafford, George, 2021) 

In this MedTech Impuls digital Mr. Matteo Gubellini,  Regulatory Affairs Manager at SoftComply Germany, and Mr. Girish Shenoy, Head Technical Service at MicroGenesis Germany, will explain how modern technology and tools like Atlassian and Gitlab can be a great choice for compliance teams to keep up with the changing regulations and emerging risks, while ensuring compliance is integrated into their organization, rather than being an afterthought.

Program
 
- How to implement ISO13485, IEC62304, FDA 21 CFR 820 compliant Quality Management System documentation 
- How to add FDA 21 CFR 11 compliant document control workflows 
- How to Capture and Freeze the dynamic content 
- How to manage Medical Device Risks in Jira and report them 
 
 
Experts

Mr. Matteo Gubellini -  Regulatory Affairs Manager – SoftComply Germany
Mr. Girish Shenoy – Head Technical Service – MicroGenesis Germany
 
 

This event is free of cost!


Registration
Click here to register!


Organizer
Forum MedTech Pharma e.V.

Contact person: Jürgen Frickinger (frickinger@medtech-pharma.de)