The demands in the medical technology field are constantly increasing – both in terms of regulatory requirements and quality assurance. This means that the documentation for products needs to be complete, correct and traceable throughout the product's entire life cycle. Advantum Dossier Management MedTech is a ready-made solution for creating, maintaining and archiving product documentation from idea and development to finished and approved medical technology product.
Efficient and quality-assured dossier management
The system provides a clear framework for how documentation should be structured and managed. With support for DHF (Design History File), DHR (Device History Record), DMR (Device Master Record) and Technical file, the solution meets the requirements of both ISO 13485 and EU MDR.
Advantum Dossier Management MedTech simplifies the documentation process and ensures that all files are stored in a standardized structure. You get full control over documents, product versions, risk management and approval processes – without having to manage separate systems or manual routines.
Advantum Dossier Management MedTech supports
DHF (Design History File)
The Design History File is the heart of the technical documentation for a medical device. It contains information about the entire design and development process, including design plans, risk analyses, verification results and design changes. In Advantum, DHF documentation is managed in a structured and version-controlled manner, with clear relationships between documents and product versions. This ensures that every step in the design history is traceable, reviewed and approved.
DHR (Device History Record)
The Device History Record collects all the information that shows that each individual product was manufactured in accordance with approved specifications and processes. Advantum makes it easy to document manufacturing data, test results and inspection reports. All information can be linked to the correct product version and manufacturing batch, which facilitates both internal follow-up and external audits.
DMR (Device Master Record)
The Device Master Record describes the complete set of instructions, specifications and materials used to manufacture the product. Advantum offers a structured management of DMR where all document versions, component lists and instructions are available in one place. This creates order, minimizes errors and makes it easier to ensure compliance.
Technical File
Technical file contains the complete product documentation required for CE marking and regulatory approval within the EU. Advantum helps you build and maintain technical files in accordance with the EU MDR and IVDR. The system ensures that all necessary documents – from product descriptions and risk management reports to clinical evaluation – are complete, up-to-date and correctly linked.
Structured management of documents and product versions
With Advantum you can create and manage products, product versions and associated documentation in a common environment. The system also supports the management of risk management files and associated documents, which provides a complete picture of the product life cycle and its changes over time. Classification of product versions makes it easy to follow the development and identify which documents apply to each version.
Standardized processes and quality assurance
Advantum Dossier Management MedTech is built on proven processes used in regulatory environments. Through role-based workflows, electronic signatures and version control, the organization gets a quality-assured way to create, review and approve documents. All activity is automatically logged in the audit trail for full traceability and compliance.
Features in Advantum Dossier Management MedTech
Advantum Dossier Management MedTech is proven over many years in demanding environments.
Product and version control
Create, update and structure products and their versions in a common environment. You always see which version applies and how the documentation has changed over time.
Risk management and audit trail
Link risk management documents directly to product and version. Full traceability is ensured through audit trails and clear links between related files.
Templates and standardization
Use ready-made templates for DHF, DHR, DMR and Technical file. This ensures uniform documentation and reduces the risk of errors in regulatory-important files.
Version management and signatures
All documents are automatically versioned. Electronic signing makes it easy to approve, update and track documents according to industry regulations.
Roles and permissions
Control access based on roles and groups. Only authorized users can read, edit, or approve documents, increasing security and compliance.
Microsoft Office integration
Advantum is a partner with Microsoft, which means that there is full integration with Outlook, Word, Excel and PowerPoint.
Thoroughly tested by leading companies
Advantum Dossier Management MedTech has been developed together with several of Sweden's leading companies and is based on the long experience we have in developing solutions for companies and organizations within MedTech.
FAQ about Dossier Management MedTech
MedTech dossier management is about collecting, structuring and tracking all documentation connected to the development, manufacturing and approval of medical devices – from idea to market.
The DHF documents the design and development process, the DHR describes the manufacturing of each product, and the DMR contains all the specifications and instructions for how the product is to be manufactured. Together, they form the basis of the Technical File.
Yes. The system supports documentation according to MDR and IVDR and helps companies build and maintain technical files that meet regulatory requirements.
Absolutely. Advantum is prepared for validation according to international standards and is already used by several validated organizations within Life Science and MedTech.
Customers include well-known players such as Karo Healthcare, AstraZeneca, Pfizer, Cobra Biologics and NorthX Biologics – all with high demands on quality, safety and regulatory compliance.
Life Science and Pharma companies that use Advantum
Frontgrade Gaisler chooses quality-assured DMS
Frontgrade Gaisler, a world leader in embedded computer systems for the aerospace industry, chose Advantum to quality assure its document management. They needed a flexible system that could grow with the business and handle critical information securely.
Moberg Pharma – dossier management within pharma
Moberg Pharma has chosen Advantum Dossier Management Pharma to streamline and quality-assert the entire process from idea to finished product. The system ensures compliance with the industry's strict requirements and provides full traceability.
SenzaGen – document management as a service
SenzaGen uses Advantum as a Service (SaaS) to manage their documentation in a secure, web-based environment with data stored in Sweden. With Advantum, they avoid investing in hardware and gain access to powerful, modern system support.
Niconovum (British American Tobacco) – dossier management
Niconovum has chosen the Advantum Dossier Management Pharma service solution to meet regulatory requirements and streamline document management. The company develops nicotine products under the Zonnic® brand.
BioArctic - new Life Science case
BioArctic, a research-intensive biopharmaceutical company in CNS diseases such as Alzheimer's and Parkinson's, has chosen Advantum as their document and quality management system software. With Advantum, they get a validatable software solution specifically developed for Life Science.
Other well-known customers
In addition to these, AstraZeneca, Orexo, NorthX Biologics and Alligator Bioscience have also chosen Advantum for their DMS and eQMS software needs.
Operation
Advantum can either be installed in your server environment, in the cloud, or you can let us take care of the operation of Advantum in a strictly controlled server environment. Get in touch and we'll help you find the best operating solution!
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