Safeguarding Quality and Compliance for Every Device
Our Medical Device Audit Services ensure that your products meet the highest standards of quality and compliance. From design controls to post-market surveillance, we assess every aspect of your device operations to safeguard your reputation and enhance patient safety.
Medical Device Audit Coverage:
- Quality Management System (QMS): Assess compliance with ISO 13485 and industry best practices.
- Design Controls: Review risk management, product design and validation process.
- Document Control: Evaluate document management and change control procedures and traceability systems.
- Supplier Management: Ensure third-party suppliers maintain high standards of quality and compliance.
- Production and Process Controls: Verify that manufacturing processes consistently produce high-quality devices.
What is a Medical Device Audit?
A medical device audit is a systematic inspection of the processes, systems, and operations involved in the manufacturing and management of medical devices.
This audit evaluates compliance with global regulations, such as ISO 13485 and FDA 21 CFR Part 820. These regulations make sure that the devices are safe for patient use and consistently meet performance expectations.
Covering everything from initial design and development to production and post-market activities, a medical device audit provides a complete lifecycle assessment to ensure product quality and regulatory compliance.
How Do We Approach Medical Device Audits?
At RxCloud, we employ a detailed, lifecycle-driven approach to medical device audits, addressing every critical stage of your product's development and distribution.
1. Pre-Audit Planning
We begin by understanding your business needs and regulatory requirements. We customize the audit to align with your specific medical device and compliance requirements as well as the regulatory landscape.
2. Document Review
Our expert auditors meticulously review your documentation—design controls, production processes, quality management systems, and regulatory filings—to ensure all processes align with industry standards.
3. On-Site Inspections
We perform thorough on-site evaluations of your manufacturing facilities, equipment, and processes to confirm that they meet the required regulatory and safety standards.
4. Risk Management and Compliance
Our auditors assess how well risk management systems are integrated into your operations, ensuring compliance with regulations such as ISO 14971. They also evaluate and suggest recommendations for the overall effectiveness of your Quality Management System (QMS).
5. Audit Report & Actionable Insights
After the audit, we provide a comprehensive report with detailed findings and actionable recommendations to improve your systems, ensuring ongoing compliance and product safety.
Ensure Compliance and Quality with RxCloud Audits
Our comprehensive audit process helps ensure that your medical devices consistently meet the highest standards of quality and safety, enhancing patient outcomes and safeguarding your reputation.
Ensure compliance and protect your reputation with RxCloud’s Medical Device Audits. Get in touch and schedule one today.
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