FDA and CE-IVD Compliance
The Food & Drug Administration (FDA) as well as the CE-IVD market have defined strict rules for the approval of medical devices and their software and demands exact documentation of their observance.
Successful approval for the US and the CE-IVD market
- Quality system in compliance ISO 13485 and 21CFR part 820
- Electronic records and signatures according to 21CFR part 11
- Software Development Lifecycle compliant with ISO 62304
- Usability Engineering for Medical Devices according to ISO 62366
- Risk Management in compliance with ISO 14971
- All steps completely traceable
The Food & Drug Administration (FDA) has defined strict rules for the approval of medical devices and their software and demands exact documentation of their observance.
apartis assists you in the production of your documentation for the required approval level, generally a minimum of 510(k)-approval.
We completely cover both the specification and the test areas. We begin by examining the status of your specifications and the validation process. With the help of reverse engineering we analyze your software, generate a complete trace matrix and determine the extent of the test.
Once the test design has been decided upon we conduct examinations at different levels, and document procedures and results according to the guidelines. Extensive risk analyses complete the spectrum.
If required we also assist you with the conceptual design and execution of clinical studies, especially in the areas of data acquisition, analysis and presentation of the results.
apartis case study: FDA-Compliance