MEDICAL DEVICE REGULATIONS AND QUALITY MANAGEMENT SYSTEM IN CONFLUENCE

This live webinar will walk you through the basics of medical device regulations and how to build a compliant Quality Management System in Confluence with the help of SoftComply eQMS and the MediCompli Solution. We will show you how to implement ISO13485, IEC62304, FDA 21 CFR 820 compliant Quality Management System documentation in Confluence and how to add FDA 21 CFR 11 compliant document control workflows in Confluence. For recorded demo video, please visit our YouTube channel.

MEDICAL DEVICE RISK MANAGEMENT IN JIRA

This live webinar will walk you through the basics of medical device risk management in Jira. We will show you how you can do ISO14971 compliant hazards analysis as well as FMEA with SoftComply Risk Manager app in Jira, how to link risks with requirements and test cases, and how to report risks. For recorded demo video, please visit our YouTube channel.

BUILDING MEDICAL DEVICE RISK TRACEABILITY IN JIRA & CONFLUENCE

This live webinar will walk you through the basics of building traceability between risks, requirements and test cases in Jira and Confluence. We will show you how you can manage medical device risks in Jira with the SoftComply Risk Manager app and how you can build custom traceability matrices in Confluence. For recorded demo video, please visit our YouTube channel.

INTRODUCTION TO MEDICAL DEVICES

This introduction to Medical Devices will bring you through the main aspects of this market. You will acquire the key concepts and requirements for Medical Devices around the world.

INTRODUCTION TO ISO 13485

Introductory course to ISO 13485. You will be presented with an overview of the ISO 13485 standard and main requirements of a Quality System for Medical Device companies.

IEC 62304 MEDICAL DEVICE SOFTWARE – SOFTWARE LIFE CYCLE PROCESSES

Base course on IEC 62304. You will acquire knowledge on the different aspects of the lifecycle process for software in Medical Devices.

ISO 14971 – RISK MANAGEMENT

Comprehensive course on ISO 14971. You will acquire all necessary skill to create, develop and maintain a Risk Management File for medical devices.

CYBERSECURITY AND MEDICAL DEVICES

Introductory course on the cybersecurity requirements for Medical Devices. Detailed overview of the different regulations, standards, guidance documents and requirements.

JIRA BASICS

JIRA WORKFLOWS, NOTIFICATIONS AND AUTOMATION

JIRA PERMISSIONS AND SECURITY

CONFLUENCE BASICS

This training will provide you with an introduction to Confluence concepts from the end user perspective. By the end of this training course, the users are aware of all the various options they have in Confluence  i.e. they can ask their Confluence Admin the right questions regarding the setup they wish to achieve. Also they know how to organise their documents and collaborate with other in Confluence!

SERVICES FOR SOFTCOMPLY eQMS

• Customization of SoftComply eQMS. • Management Review.

COMPLIANT SYSTEM SETUP

• Configuration of the system to comply with the requirements of 21 CFR 11. • Training.