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We can support your projects at various stages and help them to succeed.
- Before development in the standards research and specification of the medical device.
- During development in the compliant implementation, in particular through reviews of implemented requirements.
- During verification and validation by supporting the creation of test specifications and product certification. In particular also in the creation of the usability file.
- Throughout the entire life cycle in the creation of risk management files and software documentation.
- And finally with the submission to notified bodies and authorities for the purpose of approval / conformity assessment / registration.
The quality management system can be quickly established and maintained with our support in these areas:
- Creating management manuals and process descriptions*
- Conducting internal and supplier audits in both German and English.
- Validation of software applications in the quality management system.
* We do not use templates in which your company name is entered by means of search/replace and you then have to follow the template and bend yourself! We write the documents from scratch, adapted to your processes and the way you already work. This reduces the impact on your daily work and is ultimately easier to implement and even cheaper!
For micro and small businesses, we can also offer the “person responsible for regulatory compliance” (PRRC) as an external service.
Has “the child already fallen into the well” and you received deviations from authorities or notified bodies? In remediation projects we help to eliminate the deviations in the required time. Do not hesitate to seek support in good time in the event of deviations, the clock is ticking!
Thanks to the contacts to development service providers, testing laboratories and certification bodies, we can ensure that projects are completed quickly.