Regulatory partner for design and development
Why regulatory support?
There is long way for a device to reach the regulatory approval. However, already in the early pre-market phase, the design and development activities must comply with applicable regulatory requirements from the very beginning.
Therefore, Meliora Compliance offers to act as the regulatory partner for your design control activities, from the concept, through testing and clinicals, until the regulatory approval and design transfer.
We offer the following services:
- We will help you in the creation of your clinical and regulatory strategy
- We will support you in setting-up the design and development part of your QMS and the creation of your standard operating procedures for design control activities in compliance with ISO 13485 and/or US FDA 21 CFR 820
- We will support you in the design and development planning for your device
- We will support you in gathering the design inputs, including the determination of the intended use
- We will determine the harmonized/recognized standards, and other guidance documents applicable to your device
- We will participate in the creation of your risk management file according to ISO 14971
- We will help to set-up your design verification and validation protocols
- We will support you in selection and qualification of testing laboratories
- We will participate at your design reviews
- We will engage in early discussions with your EU notified bodies, US FDA, and other regulators, including pre-submissions to US FDA
- We will provide regulatory support to obtain regulatory approvals for your pre-market clinical studies from ethics committees/IRBs and national competent authorities/US FDA
- We will support you in setting up and maintenance of your Design History File (DHF)
- We will support you in the change control for your device, as well as the design transfer activities.
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