What We4 Regulatory offers

We4 Regulatory guides MedTech, Digital Health and Life Science companies through every stage of MDR and IVDR compliance, ensuring safe, certified medical technologies and smoother market access.

MDR / IVDR and CE marking support

• Strategy and operational support for MDR/IVDR conformity assessment and CE marking of medical devices and software.

Regulatory documentation and clinical evaluation

• Drafting and maintenance of technical documentation and clinical evaluation reports to demonstrate safety and performance.

Notified body interface and submissions

• Management of submissions, questions and responses with Notified Bodies to streamline reviews and approvals.

Post‑market surveillance and vigilance planning

• Design of PMS and vigilance plans, data collection and reporting to monitor device performance in real life.

Training and regulatory awareness for internal teams

• Tailored training sessions that strengthen internal regulatory skills and keep teams aligned with evolving standards.

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