Technical documentation for medical technologyThere is hardly an application which places requirements on documentation which are as varied as those for medical technology. Medical technology includes both simple instruments (e.g. scalpel, clamps and hooks) and sophisticated instruments and equipment (e.g. measuring and ultrasonic devices), as well as highly complex machines (e.g. computer tomographs).
The documentation and the information needs of the users are as diverse as the products. While it is not to be expected that a surgeon consults his scalpel's instructions for use before an operation, in the same way medical specialists are hardly in a position to operate a tomograph as prescribed without the instructions.
- We familiarize ourselves with your products and their applications.
- We test the practicability of various international standards that effect the documentation, e.g. the standard 92/42/EEC or FDA regulations (21 CFR Part 11).
- We prepare a concept for fulfilling special requirements, e.g. for the traceability of the documentation.
- We coordinate the preparation process and necessary intermediate publications with you, e.g. when testing for approval.
- We set up an editorial environment suitable for your requirements.
- We research the information at your location or at the operating sites.
- We create information, prepare graphics and publish the documents.
- We integrate your corrections and modifications.
- We prepare publications for the approval and delivery of the product.
Advantages for you:
- Concentration on your core business
- Relief of your developers and technicians
- Cost savings and quality improvement with well-established processes and a powerful infrastructure
- Documentation available on time for the approval and delivery of the product