eQMS Innovation
eQMSInnovation the right solution for your regulatory compliance.
Affordable eQMS solution for everyone
The eQMS has been configured by Regulatory professionals providing you with affordable electronic Quality Management System using Atlassian Jira® & Confluence® Software Integration, to help you deliver quality products.
A single solution for many QMS certifications
Build as many QMS system documentation and records in one platform.
Keep records for different QMS systems in a single platform structure (ISO13485 , MDR 2017/745 QMS , ISO9001 or ISO27001)
Comply with Regulations and Standards
Alignment to ISO13485, FDA’s 21 CFR820, ISO9001, ISO27001, MDSAP, IEC62304 for Software Development Lifecycle, and ISO14971 for Risk Management are key to your product approval success.
Comply with the regulations and standards by using our eQMS solution.
FDA 21CFR 11 Compliant solution
Work within an FDA regulated environment, then you might need to setup Confluence® in accordance with the FDA CFR 21 part 11.
Get advice from our regulatory experts in regards to the optimal setup approval workflow for your organization.
Software as a medical device (SaMD)?
Build a single solution for IEC62304 compliance.
Structure your product technical file documentation by exporting your Atlassian Jira® User needs, Functional specifications, Hazard Risks, Testing Reports and Plan, directly to Confluence.
21CFR 11 Compliant solution for approved electronic signature.
Regulatory
eQMSInnovation assist healthcare organizations in achieving conformance with global regulations, and help obtaining ISO or UKCA/FDA/CE certification.
eQMS
1-Week eQMS Implementation
We will have your customized eQMS up and running in just one week, including the import of your existing documents and the setup of your workflows.
Experience a swift transition to an efficient system designed to meet your needs.
Prebuilt templates
eQMS Innovation provides a selection of prebuilt templates to support compliance with key industry standards, including ISO 13485, ISO 14971 (Risk Management), IEC 62304 ( Software Lifecycle), IEC 62366-1 (Usability), ISO 9001, and 21 CFR 820 FDA requirements.
Services Overview
1
If your organization plan to implement an electronic quality management system compliant with ISO13485, 21CFR820, 21CFR 11, ISO9001, ISO27001, MDSAP, we can help you meet many of the requirements of these standards, by using Atlassian Jira® & Confluence® Software Integration.
As part of implementation, get our documentation templates for free!
2
Do you need ISO 13485 or QMS MDR 2017/745 for an effective implementation of the New European Medical Device Regulations?
Our Regulatory Affairs and Quality Assurance team can help you understand, plan and implement both ISO 13485, and MDR 2017/745 QMS.
As part of implementation, get all our ISO 13485/MDR QMS templates for free!
3
We help medical device manufacturers to meet the requirements of the Regulations on Medical Devices. We provide our expertise from help writing the regulatory strategy, guidance and support during all stages of product development, to review product technical files documentation for a successful product registration.