Medical Device Audits

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

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.

What is a Medical Device Audit
Medical Device Audit Inspection

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.

Contact us today!

Creating Values

Customer Testimonials

Hear from our esteemed customers how our differentiated solutions & services delivered value

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“Our experience with RxCloud for Performance Engineering as a Service has been excellent. With custom executions targeting varied user bases and simulations of real user conditions across different geographies, their team ensured a seamless user experience. They greatly helped reduce our testing cycle times and capital expenditure costs. They have truly delivered outstanding results, driving efficiency in our operations.”

Director of Quality and Operations at a Leading CRO based out of North Carolina, USA

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“Utilizing RxCloud services to streamline our test cycles for Veeva Safety Docs has been transformative. They effectively removed dependency on resources and technical knowledge for test executions and ensured a remarkable 90% reduction in cycle times.”

Chief Information Officer at a Leading Pharmaceutical Company based out of California, USA

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“Our partnership with RxCloud for End-to-End Audit Services has been exceptional. Their team ensured timely audits, global coverage, and a 35% cost reduction with their Fixed Price Managed Services Model.”

Director of Quality and Compliance at a Leading CRO based out of North Carolina, USA

Medical Device Audit Services FAQs

What are medical device audit services and why are they important?

Medical device audit services (also called medical device auditing) are systematic inspections of a company’s device manufacturing and quality processes. These compliance audits verify that your operations meet global regulations (such as ISO 13485 and FDA 21 CFR Part 820) and the highest quality standards. By examining everything from design controls to post-market surveillance, these audits help prevent quality issues, ensure patient safety, and protect your company’s reputation. In short, medical device compliance audits are essential for regulatory compliance and consistent product quality.

What does an ISO 13485 medical device audit involve?

An ISO 13485 medical device audit is a specialized quality audit of your Quality Management System (QMS) against the ISO 13485 standard. Our ISO 13485 audit services review your QMS documentation, design controls, risk management, supplier processes, and production controls to ensure full compliance. In practice, this means checking that document control, validation procedures, and corrective actions all meet industry best practices. These audits are essentially medical device quality audits focused on ISO 13485: they help manufacturers demonstrate regulatory compliance and continuously improve product safety and effectiveness.

How do FDA medical device audits (21 CFR Part 820 audits) ensure compliance?

An FDA medical device audit (covering 21 CFR Part 820) evaluates your processes against the FDA’s Quality System Regulation. RxCloud’s auditors verify compliance with 21 CFR Part 820 by examining your design controls, production processes, documentation, and traceability. This ensures that devices are manufactured to FDA requirements and are safe for patient use. In short, these audits confirm adherence to U.S. regulations and highlight any gaps so you can fix issues before an FDA inspection.

What is the Medical Device Single Audit Program (MDSAP) and do you provide MDSAP audit services?

The Medical Device Single Audit Program (MDSAP) allows a single audit to satisfy the requirements of multiple regulatory authorities. In an MDSAP audit, a recognized auditor can assess your medical device QMS against the rules of participating agencies (e.g. FDA, Health Canada) at once. RxCloud’s MDSAP audit services help manufacturers meet these global requirements with one streamlined audit, reducing duplicate effort. Our medical device regulatory compliance services include MDSAP audits, so you can confidently sell devices in multiple markets after a single comprehensive audit.

What is the difference between a medical device internal audit and an external audit?

Internal audits and external audits serve different purposes but both improve compliance. Internal audits are conducted by or for the company itself to check that its processes work as intended. External audits are performed by third parties or regulators (such as notified bodies or FDA inspectors). Both types examine your QMS and procedures, but external audits have formal regulatory consequences. RxCloud can assist with both – we help plan and execute thorough medical device internal audits to prepare your QMS, and we also provide external auditing support to ensure you meet certification or regulatory inspection requirements. Each audit—internal or external—helps strengthen quality systems and regulatory readiness.

What does a medical device risk management audit involve?

A medical device risk management audit reviews how your organization identifies, evaluates, and controls product risks. In these audits, RxCloud’s experts examine your risk management system and processes for compliance with standards like ISO 14971. We check that risk analyses are properly documented, hazards are assessed, and controls are implemented and reviewed. The audit ensures that risk management is integrated into design and manufacturing, which is crucial for maintaining device safety and regulatory compliance.

What is a design control audit for medical devices?

A design control audit examines the processes around device design and development. During this audit, we review your design history files, design reviews, validation protocols, and change control procedures to ensure they meet regulatory design control requirements. For example, our auditors verify that product design outputs match the inputs and that risk management was applied throughout development. This type of audit helps prevent defects and ensures that the device design process is compliant with industry standards and regulations.

Why are supplier audits important for medical device companies?

Supplier audits ensure that all parts and services you buy meet quality and regulatory standards. A supplier audit for medical devices examines third-party suppliers to confirm they maintain high standards of quality and compliance. By auditing suppliers, you reduce the risk of defects in components and ensure traceability of materials. This is a key part of medical device audit services: checking your supply chain gives you confidence that every piece of your product meets requirements. RxCloud’s auditors will review supplier quality systems, contracts, and controls so you can avoid issues before they impact your device.

What is a medical device quality audit?

A medical device quality audit is a comprehensive review of your Quality Management System and related processes. It covers multiple areas, including:

  • Quality Management System (QMS): Assess compliance with ISO 13485 and industry best practices.

  • Design Controls: Evaluate risk management, product design, and validation procedures.

  • Document Control: Check how documents and change controls are handled to ensure traceability.

  • Supplier Management: Ensure third-party suppliers follow quality standards.

Production and Process Controls: Verify that manufacturing consistently produces high-quality devices.

Together, these checks ensure that your entire quality system works effectively to maintain device safety and compliance.

Why choose RxCloud’s medical device regulatory compliance services?

RxCloud offers global expertise and a proven process for medical device audits. Our services ensure that your products meet the highest standards of quality and safety, protecting patients and your reputation. We cover all major regulations – ISO 13485, FDA 21 CFR Part 820, EU MDR, MDSAP, etc. – providing comprehensive medical device audit services worldwide. With RxCloud, you get detailed actionable reports and recommendations to fix issues and improve your Quality Management System. In short, our experienced auditors and global approach make RxCloud an ideal partner for all your medical device auditing and compliance needs.