Audits & Remediation – Preparing for Regulatory Success & Compliance Stability
An FDA, ISO, or MDSAP audit is an essential checkpoint for medical device manufacturers, ensuring regulatory compliance and long-term operational integrity. For startups, the first audit can be daunting, and failure to meet regulatory standards can lead to warning letters, investor concerns, or FDA watch lists, potentially jeopardizing business viability.
At Realistic Quality Solutions (RQS), we help companies prepare for regulatory audits, mitigate compliance risks, and develop robust remediation strategies to ensure adherence to FDA, ISO, MDSAP, and global regulatory frameworks.
Comprehensive Audit Preparation & Execution
- Mock FDA, ISO, & MDSAP Audits – Simulating the Real Inspection
- Departmental Inspection & Regulatory Process Review
- Corrective Action Planning & Remediation Strategy Development
- Regulatory Response Writing & Follow-Up Compliance Coordination
- Remediation & Compliance Reinforcement Following Regulatory Action
MDSAP Audits & Multi-Country Regulatory Compliance
For manufacturers seeking Medical Device Single Audit Program (MDSAP) certification, RQS supports multi-country regulatory alignment, ensuring compliance across:
- FDA (United States) – Adherence to QSR regulations, post-market reporting, and cybersecurity guidance.
- Health Canada – Compliance with ISO 13485 and Canadian Medical Device Regulations (CMDR).
3. Europe (EU MDR) – Audit readiness for CE Mark certification and conformity assessments
MDSAP audits demand strategic preparation and remediation planning—RQS ensures organizations meet international compliance expectations while reducing audit burdens across multiple jurisdictions.
An audit is just the beginning—RQS supports companies in continuous compliance management, ensuring sustained regulatory success beyond initial approval via:
Let’s build an audit readiness framework that ensures predictable, controlled, and stress-free regulatory inspections