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.

Our solution