Regulatory intelligence solution
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Medical devices, diagnosis, innovative therapies…
We support you on all issues of compliance, quality, regulation and development of product / market strategy.
nexialist offers a structured solution to assist companies in the marketing of safe and effective innovative medical products in a controlled time and optimised costs.
All missions are carried out according to structured methodology and in compliance with ISO 16114 “Consulting Service Management”.
Each of our interventions can be carried out in three levels of involvement:
- Level 1: we provide expert support;
- Level 2: we collaborate in drafting documents and defining actions to be taken and monitoring;
- Level 3: we support the realisation of documents or management of actions based on the customer’s raw knowledge and validation of actions and texts.
These levels can be articulated within the same mission as the issues addressed.
Design & development
Internal & external audit
Technical file / STED