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Electronic Quality Management System (eQMS)

eQMS solutions

An efficient, user-friendly and modern ISO 13485-compliant electronic Quality Management System delivered as a complete solution for medical device manufacturers.

 

eQMS services

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:

  • Quality Manual
  • Standard Operating Procedures (SOPs)
  • Registers
  • Forms and templates
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.

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.

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Excellence for customers

Our customer-centric approach means that our client’s needs guide our focus to create impactful results.  

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Reliability you can trust

We prioritize transparency, dependability, and delivering high-quality results. 

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Assured solutions

We deliver agile, tailored solutions through deep expertise and a commitment to excellence.