Audit Preparation & Support Services: Turn Regulatory Scrutiny into Strategic Advantage
Audits are an inevitable and critical part of the medical device and IVD lifecycle. While essential for market access and compliance, they can be disruptive, resource-intensive, and stressful—especially with the expanding burden of Notified Body (MDR/IVDR), UKCA, FDA, and MDSAP audits.
Medivdpharma (MIP) provides comprehensive audit support services to help you navigate this complex landscape with confidence. We ensure you are always prepared, transforming audits from a source of anxiety into a seamless and successful validation of your quality systems.
Our Comprehensive Audit Support Services:
We offer end-to-end support to minimize disruption and maximize your chances of a successful outcome.
- Proactive Audit Preparation & Gap Analysis
- Internal Audit Program Support
- Mock External Audits
- Audit Hosting & Registered Address Services
1. Proactive Audit Preparation & Gap Analysis
We conduct thorough pre-audit reviews of your technical documentation and Quality Management System (QMS) to identify and rectify potential non-conformities before the auditor arrives.
- Technical File Review: Ensure your documentation is complete, coherent, and compliant with MDR, IVDR, or other applicable regulations.
- QMS Gap Analysis: Assess your quality processes against ISO 13485 and regulatory requirements to uncover and address weaknesses.
2. Internal Audit Program Support
- Strengthen your internal processes and foster a culture of continuous improvement.
- We conduct independent, objective internal audits to ensure ongoing compliance.
- We help you establish and maintain a robust internal audit schedule and methodology.
3. Mock External Audits
Experience the most realistic audit simulation to build team confidence and readiness.
- Realistic Dry-Run: Our experienced auditors, many with former Notified Body experience, simulate the entire audit process, from opening meeting to close-out.
- Stress Test Your Systems: Identify vulnerabilities in your response strategies and documentation retrieval under pressure.
- Team Training: Coach your staff on how to respond to auditor questions clearly and concisely.
4. Audit Hosting & Registered Address Services
For international companies, we act as your local representative, simplifying the audit logistics.
- Audit Hosting: We provide a professional facility and manage the logistical coordination for the audit on your behalf, ensuring a smooth process.
- Registered Address: We offer our UK/EU address to serve as your official contact point for regulatory authorities, fulfilling legal requirements without a physical presence.
Why Partner with MIP for Your Audit Success?
Formulating and implementing business goals. We begin with an in-depth analysis of your business and market to identify opportunities and challenges. From there, we work with you to define clear, actionable.
Expert Led
Our team includes veterans with firsthand experience from top Notified Bodies and regulatory agencies. We know exactly what auditors look for.
Reduce Business Disruption
Our proactive preparation and management allow your team to stay focused on core business activities with minimal downtime.
Build Confidence
Walk into any audit with the peace of mind that comes from thorough preparation and expert guidance.
Avoid Costly Findings
Prevent major non-conformities, corrective actions, and potential market withdrawal by identifying and fixing issues upfront.
