2017/745/EC (MDR) – German Medical Devices Act (MPG) – ISO 13485
You can reduce your documentation costs by following a clear risk management philosophy. We design the necessary process and the file.
This will allow you to develop medical devices safely and make them fit for use right from the start.
LinnB acts as a multiplier in every functional area of your company – from production to sales & distribution.
With us you can …
… optimize your company’s processes according to ISO 13485
… reliably implement key standards such as ISO 14971, IEC 60601, IEC 62304, etc.
... prepare intended use, usability and clinical evaluations
… create process instructions and templates
… have your project work performed externally and guide projects to their goals
always works goal-oriented according to the principle “if…, then…” and is known for pragmatic solutions.
You meet the requirements of the standards.
At LinnB we love to solve problems and not only discover them. Problem solving follows a certain method at LinnB GmbH which includes different views on the issue.
These views are technical, organizational and process oriented and make the main difference to our competitors. Usually other focus on one view, we focus on all three of them.
Our procedure is based on the TOP model developed by us.
TOP stands for:
Integration of requirements on a technical level (Development process integration), organizational level and procedure orientated level.