Approvals in the USA
Approval of a medical device in the USA by the Food and Drug Administration (FDA) is a challenge. We support you in bringing your product safely and successfully to the US market.
Cybersecurity
Medical devices must be secure against cybercrime. In order to protect them against unauthorized access, medical products must be developed and produced in a trustworthy manner.
The FDA plays a pioneering role in this area. We support you with:
- applicable cybersecurity regulations,
- specifying the communication environment,
- identifying vulnerabilities,
- developing threat scenarios,
- security risk scoring,
- treatment of off-the-shelf software,
- documentation for approvals and post-market
FDA Inspection
The Food and Drug Administration (FDA) conducts inspections of companies.
FDA inspections involve considerable effort and are scheduled at short notice. Significant deviations could lead to the suspension of sales of the medical devices in the USA.
We make them “FDA-Ready”:
- Project planning of the FDA inspection
- Completion level of the QM system according to 21CFR 820
- Document check
- Identification of deviationsInitiate corrective measures
- Compiling the expected information and its presentation
- Training of employees
- Organization of the inspection including back-up office
- Mock audit
- Accompaniment of the FDA inspection
- Administrative processing
MOCK Audits
Mock audits are used to check FDA readiness and to prepare or practice all participants for the actual FDA inspection. In particular, they serve to obtain information where there are still gaps in an emergency. We offer
- Preparation and planning of mock audits
- Training of participants
- Conducting the mock audit
- Quantitative and qualitative evaluation and follow-up of the mock audit with suggestions for improvement