eQMS solutions
An efficient, user-friendly and modern ISO 13485-compliant electronic Quality Management System delivered as a complete solution for medical device manufacturers.
Electronic Quality Management System (eQMS) solutions
Reliable eQMS solutions
We have delivered dozens of eQMS systems to customers in Finland and across Europe. The eQMS solution is built on Atlassian Jira and Confluence—providing cost effectiveness, reliability and scalability to support your growth.
Document templates
Our comprehensive document template package is a great starting point for your eQMS.
The package is comprised of a high-quality, up-to-date set of documents developed and refined over many years, including:
Versatile and compliant eQMS documentation environment
The system includes:
- A compliant document approval workflow
- User roles and permissions
- Training records
- Document history and versioning
- Traceability and change management
- A complete structure for your entire QMS
Our quality and regulatory experts can also support you with content creation, if needed.
Quality management processes as part of the eQMS
We tailor electronic quality management processes according to your needs, such as CAPA and feedback handling. These digital processes ensure efficient, user-friendly, and reliable quality management operations.
We can also build a full development environment for medical device development on the same platform—covering the entire lifecycle from idea to release and maintenance.
Book a free eQMS demo
Discover how our eQMS solution can support your quality management processes. Contact us to book a free demo of the system.
Meet our expert
Miikka Kurunlahti, Systems Specialist
Meet with me to discuss your needs or get a free eQMS demo.
Explore our quality and regulatory services
Regulatory strategy
We help you develop an efficient regulatory strategy to meet applicable regulations, mitigate risks, and accelerate time-to-market for your medical device.
Market registrations
Let our team of experts support market registrations of your medical devices in the EU, US and other markets.
Digital health and cybersecurity
Dedicated regulatory and quality experts to help you streamline your medical software development and ensure that you adhere to local and global regulations.
Technical documentation
Expert support in planning, preparing and updating your technical documentation to help you ensure compliance with applicable regulations.
Clinical evaluation
Proven expertise in planning and conducting a thorough clinical evaluation that supports the regulatory approval of your medical device.
Performance evaluation
Dedicated experts in planning and conducting a thorough performance evaluation that supports the regulatory approval of your IVD medical device.
Biological evaluation
We support you in planning and conducting a thorough biological evaluation of your medical device that is compliant with ISO 10993-1.
Risk management
Medical device risk management services for setting up and maintaining your risk management process and helping you prepare your documentation.
Usability engineering
Support for your usability engineering activities, from creating a process to preparing a usability engineering file for your medical device.
Due diligence
Quality and regulatory experts ready to support your due diligence projects with comprehensive appraisals of medical device businesses.
Person Responsible for Regulatory Compliance (PRRC)
Our experts can support you in understanding the full range of PRRC responsibilities.
Quality management system services
QMS services for medical device manufacturers to help you design, implement and manage your QMS to support your organization's needs.
US FDA QMSR
Expert guidance on the US FDA's QMSR and other US regulatory requirements to help medical device manufacturers successfully enter the US market.
Auditing services
Improve your quality management system with our internal auditing services for medical device manufacturers.
Post market surveillance
Post market surveillance services to help you systematically gather and analyze data on the quality, performance, and safety of your medical device.
Our customer-centric approach means that our client’s needs guide our focus to create impactful results.
We prioritize transparency, dependability, and delivering high-quality results.
We deliver agile, tailored solutions through deep expertise and a commitment to excellence.