What is technical documentation?
With the entry of the digital age into companies, documentation by hand also underwent a change. Today, technical documentation is a priority in all industries. This is no different in a manufacturing company than in a company that specializes in medical technology.
With technical documentation, a convenient document management system can be installed in the company's internal processes. This means that, for example, the use and functioning of X-ray machines, ultrasound equipment or ECG devices can be precisely documented. In this way, it is possible to continuously improve the use of equipment in medical technology.
A company achieves good results if it uses suitable document management software for support. In the DMS software it is possible to record all work steps. The company that uses such software benefits from the fact that access to necessary data is possible at any time.
Use of Technical Documentation
Technical documentation, and therefore document management software, is used wherever work is performed by machines and systems. But analog processes can also be improved by recording the individual work steps in a document management system and keeping them ready for later access.
There are no limits to the use of supporting document management software. DMS software can do a good job in any company and in any industrial sector. The important thing is that the software meets the currently applicable specifications and has been designed for the area in which it is to be used.
Legal Requirements for Document Management in Medical Technology
The requirements that document management software in the medical field must meet are defined by Directive 93/ 42/ EEC. This set of regulations has replaced the previous regulations for technical documentation in the medical field. Every company must implement the new requirements promptly.
In addition, the following legal regulations must be observed for the technical documentation of systems and devices in the medical field:
- Medical Devices Act (MPG)
- Ordinance on Medical Devices (MPV)
- Medical Devices Operator Ordinance (MPBetreibV)
A DMS software that supports a document management system usually fulfills all legal requirements and implements the provisions set out in the individual legal standards.
Document management software in the medical sector - what are the requirements?
In the medical sector, many products are used to maintain or restore the health of patients. To ensure that these products are always used in the best possible way, they must meet normative requirements as well as legal ones.
These requirements relate, among other things, to the creation of user information and the correct indication of the company that manufactured the device in question. The latter must provide the company in which the technical device is used with all the information necessary for proper operation. With the support of technical documentation, a company can store this information and refer to it when needed.
Technical documentation also refers to the usability of a technical device. Therefore, it is important that the company documents the operation of an ECG machine or a computer tomograph and keeps it ready for constant use of these devices.
By using document management software, the company can meet all legal and normative requirements. Through regular updates, the latest technical standards are also implemented with appropriate software.
Furthermore, such software also supports the risk management of an X-ray machine or a heart-lung machine. It would have fatal consequences if a device failed and could no longer perform its normal functions. To prevent this, companies use document management software. Errors in the system can be identified and corrected more quickly. In the best case, the use of appropriate software contributes to the fact that an error can be corrected immediately after analysis.
With this kind of support, the appropriate document management system software also ensures that the company using it makes an important contribution to increasing its own quality management.
Advantages of a DMS Software for the Use in Medical Technology
The use of a DMS software brings many advantages in the medical field. If a company uses a document management system, it has all data stored in one central location. Especially in the field of medical technology, where time can save lives, this help offers an absolute advantage. If the company needs to access an important data record, the system makes this possible within seconds. Long search times are thus a thing of the past.
Software also supports easier handling of all correspondence. This is because using software relieves the burden on e-mail inboxes and saves archive space. Necessary operating instructions and important patient-specific data can be made available anywhere and at any time. With integrated version control, companies receive additional revision security.
In addition, document management software also offers several practical advantages. Where software is used, operational costs are reduced because less paper and less toner are used. Since a printer is no longer in constant use, the device no longer requires regular maintenance. Individual business processes are accelerated to such an extent that the use of DMS software can optimize the entire operational process.
If a company works with technical systems and equipment, comprehensive documentation of the individual work processes is of certain importance. However, manual processes can also be optimized if the individual procedures are documented in detail. All these areas benefit if the company installs a functioning document management system.
At best, the company can also be supported by suitable document management software. With the use of software, it is possible for all data to be stored in one central location. This eliminates the need to search for information in files that have long since disappeared into the archive. This is even more valuable when time is short.
Software also provides professional support in analyzing errors, which can never be ruled out with technical equipment. The sooner a technical defect or an error in the system is detected, the better this is for the company operating in the medical sector and using the software.
In addition, document management software forms the advantage that all legal and normative requirements have been properly implemented and with regular updates the current status of the requirements can be guaranteed.