Organising post-market surveillance
How ca I use post-market surveillance strategic tool?
Post-market surveillance is a regulatory requirement that can provide you with key pieces of information for risk control and corporate management.
By choosing Nex'PMS, you get:
- Specific tools developed by Nexialist to meet regulatory requirements;
- A global vision based on the Total Product Life Cycle approach;
- A methodology appreciated by auditors and users that allows the implementation of achievable, coherent and effective action plans.
Nex'PMS is a methodology based on:
- Involvement of all the company's services;
- Detailed analysis of all impacts on the product;
- Methodical implementation of actions that facilitates updating the risk management file and clinical assessment;
- Structuring of relevant customer attention in relation to risk management and clinical assessment;
- Regular product reviews and monitoring of the implementation of agreed actions.
Results for your business:
- A real business management tool and decision support;
- Guarantee of the company profitability;
- PMS data serve as input data for the management review;
- A clear and objective understanding of the condition of the marketed products;
- Knowledge of customer satisfaction;
- Ability to develop products with real data while taking into account the regulatory requirements and market constraints.
- A genuine tool for corporate monitoring and supporting decision-making;
- Helps ensure the profitability of your company;
- PMS data are a base data for the management review process;
- A clear and objective knowledge of the situation of marketed products;
- A clear understanding of customer satisfaction;
- The ability to upgrade the products based on factual data that include regulatory requirements and market specificities.
Non-compliance with the post-market surveillance protocol can cause:
- Significant financial losses when marketed products cost more than they earn (e.g. too much customer services relative to sales generated);
- Risk of losing a CE marking if PMS is not properly carried out;
- Potential endangerment of the company's sustainability linked to a negative drift on the efficacy and safety of marketed products.