Mitigate risk and remain compliant.
Post marketing surveillance (PMS) is organized to monitor the safety and performance of the product once used by large number of patients in the targeted population, and to ensure a sustainable risk/benefit balance.
Agreements are established with distributors in particular to define the split of regulatory responsibilities between the different stakeholders (Manufacturer/distributor). Promotional materials are developed for each market, in compliance with local regulatory requirements.
Launch, pricing, and reimbursement strategies aim to yield a favorable evidence-based assessment by national authorities, whose priorities and outcome measurement vary across markets.
The medical device’s core value dossier is adapted for local reimbursement applications.
Post-market surveillance to maintain compliance
Assess opportunities in new indications, product repositioning, need of additional clinical studies in new indications.
Collect RW data
Manage unexpected regulatory or safety issues.
- Are the post-market surveillance procedures well defined and not too burdensome? How to optimize the post-approval regulatory plan?
- How to handle manufacturing changes/issues?
- How to manage competitive markets?
- How to identify additional market opportunities?
- How to extend the indication for use?
- Will pricing need to be re-negotiated? What will be the adequate evidence to support it?