Notified body auditing is an essential process in the health technology field, where a third party evaluates a company’s quality system and documentation for compliance with MDR requirements. The most common challenges relate to documentation management, deficiencies in risk management, and inadequate staff preparation for the auditing situation.
What does notified body auditing mean in health technology?
Notified body auditing is a systematic evaluation in which an authorized third-party organization examines a medical device manufacturer’s operational compliance with requirements. The main purpose of the audit is to ensure that the company complies with the EU Medical Device Regulation (MDR 2017/745) and can safely produce medical devices.
Auditing is a central part of the CE marking approval process. Without a successful audit, a company cannot obtain the necessary certificate that authorizes the placing of products on the market in the European region. Health technology auditing focuses particularly on the functionality of the quality system, risk management processes, and the comprehensiveness of product documentation.
Meeting MDR requirements demands strict documentation and traceability throughout the entire product lifecycle. The auditing process ensures that the company’s internal processes support patient safety and quality manufacturing of products.
What are the biggest pitfalls in the audit preparation phase?
Documentation management most often forms the greatest stumbling block in health technology auditing. Companies frequently underestimate the scope and precision of required documentation. Inadequate or fragmented documentation inevitably leads to auditing difficulties.
Quality system development remains superficial in many organizations. Simply creating documents that comply with standards is not sufficient; the processes must be truly in use and under staff control. The auditing situation quickly reveals if the quality system exists only on paper and not in practice.
Risk management documentation causes particular challenges. The risk management process according to the ISO 14971 standard requires a systematic approach and continuous updating. Many companies perform risk analysis once and do not integrate the process as part of continuous product development.
Staff preparation is a critical success factor. The auditing situation is stressful, and personnel must be able to answer precise questions about their own areas of responsibility. Inadequate preparation leads to uncertainty and errors during the audit.
How does Clinipower help avoid auditing pitfalls?
We provide comprehensive support for health technology audit preparation through our expert team. Our experienced quality specialists are auditors who understand both the auditing process and the special requirements of medical devices. We can act as independent and fair auditors or prepare your organization for an upcoming audit.
In quality system development, we utilize our extensive expertise in MDR, IVDR, ISO 13485, and other relevant standards. Our outsourced quality manager service enables cost-effective access to a qualified quality specialist as part of your team. Our quality manager handles quality management systems, risk management, and regulatory communication.
In supporting risk management, we focus on patient safety and systematic risk management processes. We help create a functional risk management system that meets regulatory requirements and supports product development. Our team’s expertise covers risk management throughout the entire product lifecycle.
In meeting regulatory requirements, we support health technology companies in carrying out CE marking and certification processes. We walk with you to the finish line and ensure that your products can be CE marked and successfully certified. Our service covers product intended use definition, classification, documentation preparation, and certification processes.
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