Need reliable post-market surveillance and global compliance for your medical devices? We’ve got your back.
Compliance doesn’t stop once a medical device hits the market — in fact, it becomes even more critical. At Aptitude Solution, we support device manufacturers in meeting rigorous FDA and global regulatory requirements through robust post-market surveillance and global market readiness. Whether it’s managing adverse events, conducting 522 studies, or navigating European regulatory pathways, our experienced consultants help you stay compliant and confident.
1.
Assess & Prepare
We evaluate your post-market compliance landscape and identify any gaps or risks before they become regulatory issues.
2.
Monitor & Manage Adverse Events
Our team tracks malfunctions, serious injuries, and deaths, and handles reporting in line with FDA guidelines.
3.
Take Corrective Action
We support CAPA initiation, update risk severity/occurrence levels, and define clear trigger points for faster interventions.
4.
Ensure Global Compliance
From FDA to EU and beyond, we help you meet global post-market requirements and manage approvals and exemptions smoothly.
Services we provide
Post-Market Surveillance (PMS)
Monitor and report device-related events, ensuring compliance with FDA 21 CFR Part 803 and global standards.
Adverse Event Management
Identify risk levels, update severity/occurrence scales, and manage safety investigations efficiently.
CAPA Implementation
Set trigger levels and initiate corrective actions to mitigate identified risks and maintain quality standards.
FDA Regulatory Compliance
Assist in reporting malfunctions, serious injuries, deaths, and registration of establishments per FDA guidelines.
Section 522 & Post-Approval Studies
Conduct mandatory studies under FDA Section 522, HDE, PMA, or PDP requirements.
EU MDR & Global Market Entry
Ensure your devices meet European and international compliance regulations, enabling cross-border product distribution.
Regulatory Strategy & Consultation
Offer ongoing guidance to adapt to evolving global regulations and maintain long-term market access.
