Regulatory Affairs

Focused on solutions

We support you

Experienced resources

QUNIQUE´s experienced resources help you find the most efficient and successful way to get a new medical device or an in-vitro diagnostic device to a specific market. Our resources help you in the initial planning phase, leading up to the technical documentation compiling process and moving towards the regulatory submission of the compliance documentation.

Project manager

QUNIQUE works with experienced and reliable international regulatory professionals who can guide you in the right direction. We have experienced project managers who are capable of assuming project leadership until you are prepared for a full transfer of responsibilities to your internal resources.

Preparation packages

QUNIQUE provides tailored preparation packages including GAP assessment, clinical strategy review, technical documentation compilation, and post-market reports preparation (e.g. Summary on Safety and Clinical Performance (SSCP), Post-Market Clinical Follow-up  Report (PMCF), Periodic Safety Update Report (PSUR) etc.).

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