Quality Assurance and Regulatory Affairs
Regulatory Sustenance for Medical Devices and IVDs
Sustaining Compliance Throughout Your Device Lifecycle
Comprehensive regulatory sustenance services designed to ensure medical devices and IVDs maintain continuous compliance throughout their post-market lifecycle. Our solutions help manufacturers navigate complex and evolving global regulations – including EU MDR, IVDR, and enhanced FDA requirements – while alleviating the burden of continuous monitoring, reporting, and documentation. As regulatory expectations grow more stringent and post-market surveillance intensifies worldwide, our services deliver the strategic foundation to keep your products compliant, market-ready, and aligned with the latest regulatory intelligence – allowing you to focus on innovation and growth.
Our Offerings: Driving Compliance Excellence Globally
Proactive Drivers (Planned Activities)
These are systematic, scheduled actions embedded in lifecycle and quality management to maintain compliance:
Post-Market Surveillance (PMS):
Continuous collection and analysis of safety data per FDA and EU MDR requirements.
PSUR/PMSR Preparation:
Periodic safety and performance reporting aligned with device class and regulatory timelines.
Post-Market Clinical Follow-up (PMCF):
Ongoing clinical studies for higher-risk devices, updating evaluations and submissions.
Regulatory Intelligence & Horizon Scanning:
Monitoring global regulatory changes to anticipate compliance needs.
Quality Management System (QMS) Updates:
Incorporating new procedures or standards, triggering regulatory reviews.
Audit Findings:
Addressing non-conformities from internal, notified body, or FDA audits.
Supplier/Vendor Changes:
Evaluating impact of critical supplier modifications on device safety and compliance.
Certification Renewal:
Managing periodic renewals and associated documentation updates.
Reactive Drivers (Unplanned Events)
These rise from unforeseen issues or external changes requiring immediate regulatory action:
Change Control & Notification Management:
Handling design, material, or process changes requiring regulatory submissions.
Vigilance & Adverse Event Reporting:
Managing MDRs, FSCAs, PSURs, and incident reports within global timelines.
Adverse Events & Complaints:
Investigating device-related injuries or systemic issues, initiating CAPA and reporting.
Systemic Quality Errors:
CAPA findings triggering design or process changes and potential regulatory filings.
Technological Changes in Similar Devices:
Reassessing safety when regulators flag issues in comparable products.
New Regulatory Requirements:
Rapid updates to technical documentation and compliance processes for amended rules.
Technical Documentation Maintenance:
Updating CEP/ CER, DHF, DMR, and technical files post-change or in response to compliance gaps.
Capabilities That Set Us Apart
- As a CDMO, our early design-phase involvement enables seamless regulatory sustenance integrated across the product lifecycle.
- Global Regulatory Expertise: Proficient in FDA QMSR, EU MDR/IVDR, ISO 13485:2016.
- Advanced Compliance Systems: Leverage QMS, complaint handling, and regulatory tracking technologies.
- Proven High-Risk Support: Expertise in Class IIb/III devices and complex IVD requirements.
- Regulatory Intelligence Leadership: Proactive monitoring for evolving global compliance and market readiness.
Let's Collaborate to Strengthen Your Compliance Foundation
Contact us to begin a conversation about sustaining compliance excellence throughout your device lifecycle.