Technical File Composition
Insuring IVDR & MDR Compliance with Precision
Service Description
Develop and maintain fully compliant technical documentation that meets the rigorous requirements of the EU In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR). Our service provides expert guidance in structuring technical files, addressing conformity assessment criteria, and aligning documentation with notified body expectations. From gap analyses to full implementation, we empower medical device and IVD manufacturers to achieve regulatory approval with clarity and confidence.
Cancellation Policy
We value your time and commitment and strive to offer flexible and efficient scheduling. To ensure smooth operations and fairness to all clients, the following policies apply: - Cancellations and Rescheduling: To cancel or reschedule an appointment, please notify us at least 24 hours prior to your scheduled time or reschedule yourself using the online booking tool at no cost to you. - Cancellations or rescheduling requests made with less than 24-hour notice will incur a fee of 50% of the hourly rate, amounting to $125. - Missed Appointments: No-shows or missed appointments without prior notice will also be subject to the cancellation fee of the full hourly rate of $250. - How to Notify Us:- Contact us via [email address] or [phone number] to modify or cancel your appointment. We appreciate your understanding and cooperation in adhering to this policy, which allows us to provide high-quality service to all of our valued clients.
Contact Details
12019367191
rachel.ryll@relianceqrc.com
53 Congress Street, Jersey City, NJ, USA