Mitigate risk and remain compliant.
Post-marketing surveillance (PMS) means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventative actions.
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.
Regulatory Intelligence is carried out to ensure new or updated requirements are incorporated into the Quality Management System and regulatory technical documentation.
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.
Client Goals
Post-market surveillance to maintain compliance and improve product safety and effectiveness
Assess opportunities in new indications, product repositioning, need of additional clinical studies in new indications.
Collect Real World data
Manage unexpected regulatory or safety issues.
Challenges
- 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?
Solutions 
