TECHNICAL DOCUMENTATION SOFTWARE
Digital software for your technical documentation
Technical documentation enables comprehensive digital management and updating of all documents. This ensures compliance with regulations such as the MDR and simultaneously increases the efficiency and data security of your documentation-based processes.
Manage technical documents efficiently and securely
Compliance with the Medical Device Regulation (MDR)
Digitize processes and minimize throughput times
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Software for your technical documentation
From individual documents to our document management system and process-orientated dossier management — our ‘dls | technical documents’ module effectively supports the creation, updating and management of your technical documentation, e.g. in the context of the requirements of the Medical Device Regulation (MDR). Our process-orientated dossier management can be used in a variety of ways, e.g. to create site master files, tool logbooks, drug master files, QM documentation, project folders, validation documentation and much more.
How do you benefit from the Technical Documentation software?
Make manual documentation of dossiers a thing of the past — instead, manage them completely digitally.
Let untidy file servers with multiple storage locations and redundant folder structures be a thing of the past.
Protect your data from unwanted interference by unauthorized users and from destructive forces.
Have the modules configured according to your specific requirements to make it easier for your colleagues to familiarise themselves with the system.
Create and update your technical documentation digitally to fulfil the requirements of the MDR.
Reduce the process times for creating, revising and approving your dossiers and minimise the time spent searching for and compiling up-to-date documents.
Use d.velop documents (formerly d.3ecm) as your central information source to retrieve all relevant data at any time.
Access your data anytime and anywhere.
Here are some features of the Technical Documentation
Moreover, you can directly adopt documents from the eDMS/eQMS using the dossier template. Add additional documents and attachments to the dossier application and assign them to the respective chapters via drag & drop.
Print your dossiers or export them as a ZIP file or PDF/A. It is also possible to print and/or export only parts or certain chapters of the dossier.
Using the Drop Zone, non-controlled and controlled documents can be stored via drag & drop. Documents can also be assigned directly to the respective nodes/chapters in the dossier via drag & drop.
For each document, a preview can be displayed within the flexibly customizable reading pane.
Create templates and chapter structures for your dossiers according to your needs and define responsibilities for each part. Dossier templates, e.g. for the MDR tree structure, are automatically included when the module is implemented.
Would you like a live insight into the software?
Gain a live insight into the possibilities of process-orientated dossier management in just 45 minutes using a sample use case. Learn how our solution can support and simplify the creation and updating of your technical documentation within the requirements of the Medical Device Regulation (MDR).
Here are some features of the Technical Documentation
- Template management for various dossier structures
- Task management for processing individual chapters of a dossier (workflow)
- Seamlessly integrate into our Document Control module
- Check the completeness of your dossiers
- Check the current editing status of your dossier
- Versioning of your dossiers with easy access to all old versions
- Create comments with different priorities
- Export the entire dossier or selected parts as a PDF or ZIP file
- Print the entire dossier or selected parts of it
- Use the integrated electronic and GxP-compliant signature as well as audit trail functions
- Classification of dossiers via attributes in ECM d.velop documents (formerly d.3ecm)
Regulatory requirements for Technical Documentation
ISO 13485 MPG
Medical Device Regulation (MDR) — EU Guideline MDR 2017/745
33 Good reasons for a cooperation with Digital LS
You’re not convinced yet? You’re not convinced yet? Find out about 33 good reasons speaking for a cooperation with Digital Life Sciences GmbH. We will show you reasons from the provider’s point of view, from the software point of view and other general reasons that distinguish us.
Customer reviews of Technical Documentation
“We have been working together with d.velop AG very successfully and contentedly for years. Looking for a reliable partner for the technical documentation of our medical products, we stumbled upon the life science client. With the transition to the new structure of EU MDR, we were able to fully exploit the potential of the Life Sciences Client for us and thus facilitate the work of document creation and improve acceptance in the company.”
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Frequently asked questions (FAQs) about Technical Documentation
Are there templates for the structure of the dossier?
Templates are available for frequently used documentation, e.g. according to Annex II of the MDR 2017/745. On the basis of a structure used by you, you can also amend templates yourself or have them created as part of the introduction of the module.
Can chapter structures be adapted?
You can customize chapter structures and dossier templates or create your own.
How do I ensure that an employee adds all relevant documents to the dossier?
Using the tasks ‘Placeholders’ and ‘Document creation’ you specify which documents the dossier must contain before it can be released.
Can I use documents from the file system in the dossier?
Documents from your desktop or from the file directory can be used in the dossier. They are stored in the document management system and used from there in one or more dossiers.
Can several employees work on one dossier?
For each dossier, a main person responsible is identified, who also receives the reminders for completion or periodic review. Individual chapters of the structure can be transferred to a person partially responsible for processing.
Can documents be used more than once?
Documents are added once to the contents list of the dossier and can then be inserted at several positions in the structure. Documents can also be used in several dossiers.
Why does one use the technical documentation for the approval of a medical device?
Technical documentation is used for the approval of a medical device to provide regulatory authorities and others involved with information about how the device works, who will use it, and how it can be used safely.
What are the advantages of technical documentation software?
Software solutions for technical documentation offer comprehensive benefits that make a decisive contribution to improving processes. The main advantages include:
- Increased efficiency: Automated workflows significantly optimise the creation and management of documents.
- Improved traceability and versioning: Centralised databases enable seamless tracking of changes and effective management of document versions.
- Automatic compliance with standards: The software ensures full compliance with relevant regulations, including the MDR for technical documentation as well as ISO standards.
- Time and cost savings: By using standardised templates (e.g. templates for technical documentation), the documentation process is designed efficiently, which significantly reduces both time and costs.
These advantages not only promote quality and transparency, but also help to successfully fulfil the regulatory requirements in the industry.
What requirements must technical documentation for medical devices fulfil?
The requirements for technical documentation for medical devices include:
- Complete and transparent presentation of product information, e.g. in accordance with the Medical Device Regulation (MDR).
- Seamless integration of product documentation for medical devices and specific test reports.
- Ensuring traceability, e.g. through the use of templates for technical documentation.
- Use of a special software documentation template to fulfil regulatory requirements.
How can you create technical documentation and what tools are available for this?
Various approaches are available to you for creating technical documentation:
- Manual creation using specific Word templates for technical documentation.
- Use of specialised software solutions for technical documentation that offer ready-made templates and comprehensive structuring options to do justice to the documented processes.
- Creation of technical documentation in PDF formats to ensure easy distribution and long-term archiving.
Training is also very important, such as training on technical documentation for medical devices. These training courses promote an understanding of industry-specific standards and regulatory requirements and contribute to quality assurance.
Are the documents in the dossier updated when new versions are released?
When a dossier is released, the version is ‘frozen’, changes are only possible in a subsequent version. With the overview ‘Version statuses’ you get an overview of the document versions. To adopt new versions, create a new version of the dossier and decide which version of the documents to adopt.
For documents added to the dossier as attachments, the valid release version is always used.
Can individual documents from the dossier be printed?
Printing of documents is possible, the function depends on the specifications from the document management system (controlled — not controlled).
Is a partial export of the dossier possible?
Export as ZIP archive or PDF file is possible for the whole dossier or for selected chapters / documents.
Is the data exported from the dossier protected?
For the ZIP file, the protection is preset with a password. Furthermore, you can preset the creation of PDF/A files to prevent printing and copying and enter a watermark for each export.
Is the export logged?
The actions are recorded in the audit trail of the dossier, including the output as a ZIP or PDF file and the export of individual documents.
The audit trail stores the date and time of an activity for the actions listed below. Moreover, the ID of the user triggering the activity is stored in the audit trail entry.
Which file formats can be used in the dossier?
Documents can be inserted into the dossier regardless of the file format (PDF, MS Word, Excel, PowerPoint, PNG, JPG, TIFF, Visio)
How can our software help you with technical documentation?
Our technical documentation software is an application primarily used for managing technical documentation (“dossiers”). It can manage a large number of dossiers in the process. The software allows you, for example, to create technical documentation in accordance with MDR (EU Medical Devices Regulation). The goal here is the audit-proof management of all documents and content that arise in the life of a medical device.
We will be happy to show you how you as a user can benefit from our software for technical documentation in your company in a live webcast on the software.
Are there templates or examples for the technical documentation?
Many providers of documentation software offer comprehensive templates and examples to efficiently organise the documentation process. These include:
- Technical documentation templates: These are already structured and contain frequently used fields that ensure consistent and standardised document creation.
- Word templates for technical documentation: These templates are particularly suitable for smaller projects and allow easy customisation to specific requirements.
- Examples of technical documentation in PDF format: These serve as a valuable guide to structure and content and help users to create high-quality documents.
What are the key aspects of managing documentation software for medical devices?
The following aspects are of crucial importance when managing documentation for medical devices:
- The software should support comprehensive functions such as versioning, a release process and complete software documentation.
- Compliance with regulatory requirements, including technical documentation requirements and software documentation guidelines, is essential to ensure conformity and quality.
Overview Medical Device Regulation (MDR)
Medical Device Regulation (MDR) — Regulation 2017/745 (EU) on medical devices
The Medical Device Regulation (MDR) has been in force in the European Union (EU) since 26 May 2021. This article provides information on its content and the implementation provisions for the medical technology industry.
EU regulation customised for the medical technology sector
The ‘Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices’ came into force on 5 April 2017. It replaces the previous ‘Medical Devices Directive 93/42/EEC’. In concrete terms, this means that EU Regulation 2017/745 replaces the following previous directives in the field of medical technology:
- Directive 93/42/EEC concerning medical devices (MDD);
- Directive 90/385/EEC, active implantable medical devices (AIMDD).
The EU bodies decided in favour of a separate regulation in relation to Directive 98/79/EC on in vitro diagnostic medical devices (IVD). This directive was not incorporated into the Medical Devices Regulation. It has been replaced by the separately formulated EU regulation ‘In-vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR)’.
Binding throughout Europe since 26 May 2021
In contrast to the superseded directive, the EU Parliament’s new regulation has gained international significance. Its binding validity extends to all EU member states from 26 May 2021. It should be noted that no national legislation had been adopted by the individual member states by October 2019. This also applies to German specifics, requirements and regulations to be issued. Although there is a corresponding draft for a German implementing law, the Federal Ministry of Health expects transitional periods.
According to the current legal text, a transitional period of three years (26.05.17 — 25.05.21*) applies for implementation. Manufacturers are obliged to submit an MDR certificate by the end of this period at the latest. This is the only way they are permitted to place a product on the market for the first time.
*In the course of the COVID-19 pandemic, the date of application of the regulation was postponed to 26 May 2021.
Objective and necessity of the new EU regulation
At its core, the new regulation aims to optimise and standardise regulations for the market launch of medical technology products. The focus is on product safety and product quality. For market participants and users, the new EU regulation consists of a mixture of familiar content from the previous Directive 93/42/EEC and far-reaching innovations. The key content and procedural aspects for you and your industry include the following contents of the Brussels Regulation:
Rules for the classification of medical devices
New terms and rules lead to changes in the allocation of existing products to product classes, some of which have changed. The ‘stand-alone’ software product area, for example, is affected by these changes.
Conformity assessment procedure
In line with the regulations for classification, the conformity assessment procedure now also differs depending on the class.
Technical documentation/document management system
The technical documentation in accordance with the Medical Devices Regulation is much more detailed. The advantages for companies in terms of control and documentation become clear when you look at the new underlying, tabularly structured scheme in detail. The subdivision into individual categories in direct connection with the associated detailed requirements forms the basis for detailed technical documentation.
Clinical evaluations/clinical trials
This action point is characterised by significantly increased requirements. This applies in particular to high-risk product groups.
Corporate responsibility/safety officer
A significant change for your company comes from the EU bodies’ requirement for a responsible person responsible for compliance with regulatory requirements in their organization.
Quality management
The FDA Medical Device 21 CFR 820 (FDA = U.S. Food and Drug Administration) formulates the requirements for management systems of medical device manufacturers. In this function, Device 21 CFR 820 is a counterpart to ISO 13485. The core requirement is that procedural instructions such as document control, procurement, development and production are documented and implemented analogously.
Market surveillance mechanisms
In particular, the mandatory use of the EUDAMED database ensures more transparency. It is available as an information medium to both the public and direct competitors. The features of each medical device are mapped using appropriate links. It is also possible to trace supply chains
Ways to comply with the Medical Device Regulation
In the interest of timely compliance with the new regulation, you are the responsible person in the company. A consistent plan in terms of timing and content for converting your company to the Medical Devices Regulation is a prerequisite for your success. You should give high priority to the life cycles of your medical device portfolio. According to EU regulations, existing MDD certifications will no longer be valid on May 26, 2024. When planning, please keep in mind that your products that are already certified according to MDD must also go through the newly created conformity procedure according to MDR. Grandfathering is not guaranteed.
During the changeover phase, you are particularly challenged in your role as a manufacturer or supplier. The top priority is to name and train the person responsible for compliance with the regulations in your company (MDR Article 15). Updates to internal quality assurance procedures, documentation and changed product classification are mandatory.
Against this background, the following standardized procedure is recommended according to the following 4 points:
- Carrying out the conformity assessment regarding the product
- Issuance of the declaration of conformity
- “CE” marking of the products
- Registration of the company and products in the EUDAMED database.
Conclusion and criticism of the new regulation
With the MDR, the EU authorities have set out to create a modern, uniform solution for quality management and the market release of medical devices. Great attention is paid to the quality and safety of the products. Maybe you are one of the small and medium-sized companies in the medical technology industry who fear over-regulation due to the extensive set of rules and additional control bodies?
In particular, the assessment of conformity by the “compliance manager” to be hired is likely to become a personnel problem in the start-up phase. In hardship cases, a lack of certified inspectors could delay the certification necessary for market release. Medical technology industry associations express the fear that a bottleneck in certifications could have a negative impact on the market launch of innovative and marketable products.
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