HotlineDM, the medical device regulatory and quality hotline

The regulatory and quality hotline for medical devices

As a manager or person in charge of quality and regulatory aspects within your company, you certainly have many regulatory or quality questions that mark the life cycle of your medical device. To answer them, we decided to create HotlineDM, a regulatory and quality hotline for medical devices, allowing you to provide quick and relevant answers.

HotlineDM is:

A simple appointment to explain your problem and ask your question quickly.
A suitable response provided during the appointment or at the latest within a few days.
A dedicated and experienced team (from class I to class III).
The possibility of testing a new provider .

The hotline is suitable for:

Start-ups that are beginning to define their regulatory strategy and are asking themselves the first questions related to the marketing of their device.
Regulatory teams who want one-off support on specific issues or at more critical times: before a submission or during the response deadline to notified bodies.
Medical device subcontractors who have questions regarding the application of ISO 13485:2016.

HotlineDM works on a time credit basis. We offer four packages:

These packages are available without time limit. To process your request as quickly as possible, we offer the following method:

Book an appointment for 20 minutes.
Explain your problem during the meeting.
If the answer can be provided to you during the appointment, there is no charge.
If the level of complexity does not allow us to answer your question, one of the packages (without a duration commitment) may be offered to you.

How does our hotline work?

Cisteo's regulatory hotline service helps you quickly unblock situations and progress efficiently in your projects. With a simple question, you get quick answers thanks to a complete team of regulatory and quality experts, always available for you. Having worked for regulatory manufacturers, our employees know your needs and expectations inside out. The hotline is also an ideal opportunity to test our skills as a medical device company and benefit from our field expertise, forged by our activities as an R&D and industrial partner, design and manufacturing in a controlled environment.

The hotline answers all your regulatory questions, whether it is to determine whether your device is medical, to know its European or American classification, or to develop an appropriate regulatory strategy. We also offer advice on risk management, biological and clinical evaluation, and product specifications. For the Quality Management System, we clarify for example the applicable paragraphs of the NF EN ISO 13485:2016 standard, the relevant exclusions and non-applications, as well as the list of procedures required for a QMS compliant or not compliant with this standard.

Book an appointment with a member of the regulatory team