Quality Assurance Archives

Medical Device Cleaning Validation

Leave a Comment / Blog, Client Questions, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, UK Regulations / David Small

Cleaning validation is a critical process for ensuring the safety and effectiveness of medical devices by verifying that they are free from harmful contaminants such as biological residues, chemical remnants, and particulate matter. This process is essential for meeting stringent regulatory standards, including ISO 13485, ISO 14971, EU MDR, and FDA guidelines, which mandate thorough cleaning protocols to mitigate risks to patients and device functionality. By defining acceptance criteria, conducting risk assessments, and performing robust validation testing, manufacturers can establish consistent cleaning processes that meet compliance requirements.

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Medical Device Labelling

Blog, Client Questions, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, UK Regulations / David Small

Medical Device labelling is a key requirement of regulations world wide. Manufacturers of medical devices are required to ensure that the products they place on the market are appropriately labelled, this enables traceability, and key information to users on how to use the devices safely.

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Notified Bodies

Blog, Client Questions, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, UK Regulations / David Small

Notified Bodies are essential for ensuring product safety and compliance. Whether your business operates in the European Union (EU) or the United Kingdom (UK), understanding how to work with these organizations is vital. This blog explains the role of Notified Bodies, their importance under EU and UK regulations, and what manufacturers need to know.

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Core elements that make up quality management systems

Understanding the core elements of Quality Management Systems

Blog, Quality Assurance, Quality Management, Standards, USA Regulations / David Small

In today’s competitive marketplace, delivering high-quality products and services is essential for business success. A Quality Management System (QMS) is a structured framework that helps organizations ensure they meet customer requirements and enhance customer satisfaction. But what are the fundamental elements that constitute a robust QMS? In this blog, we will explore the basic components that form the backbone of effective quality management systems.

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FDA update of QSR to be inline with ISO 13485 for harmonisation.

5 Differences Between ISO 13485 & FDAs Medical Device QSR

Blog, Quality Assurance, Quality Management, Standards, USA Regulations / David Small

Medical device manufacturers face a daunting task: navigating complex regulatory landscapes to ensure their products meet safety and quality standards. In order to sell products in the US, manufacturers are required to comply with CFR 21 Part 820, whereas for global markets, the voluntary ISO 13485 is used. These two standards are not the same, and companies must understand the differences between them if they are to get their products to market across regions. However, with the FDA actively working to align CFR 21 Part 820 more closely with ISO 13485, the effort toward global harmonization is a promising sign for medical device manufacturers.

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A certificate that says 'ISO 13485 certified' on it - This image is used by patient guard to represent ISO 13485 quality assurance and QMS services.

What is ISO 13485?

Blog, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, Standards, UK Regulations, USA Regulations / David Small

ISO 13485 is an international standard for mapping what is required from a medical device. The system ensures that medical devices are effective and consistent throughout their life cycle, from planning and production to disposal.

Ensuring consistency is extremely important for medical devices, as patient safety could be at risk. Implementing quality management systems can also provide protection for manufacturers and their reputations, as risks can be easily identified and rectified.

Medical device regulation varies based on the classification of the medical device being manufactured. All parties are required to demonstrate compliance, from the medical device manufacturing process to the disposal of the product.

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Quality in medical devices can be divided into two areas, Quality Assurance and Quality Control in this blog we discuss the difference between the two. This image is used to represent quality, it is a clipboard with checks marks next to boxes with the words approved above it. There is a quality engineer next to it looking at a device and a spy glass over the form. On the other side of the clipboard are some boxes with barcodes on them.

Quality Assurance & Quality Control

Blog, Quality Assurance, Quality Management / David Small

Quality assurance (QA) and quality control (QC) are two important concepts in the medical device industry. Although they are related, there are distinct differences between the two. In this blog post, we will explore the difference between medical device quality assurance and quality control.

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Photograph of medical devices including blood glucose meters, injector pens and IVD test strips

ISO 13485 Standard – Quality Management System

Blog, Quality Assurance, Quality Management, Standards / David Small

The ISO 13485 standard was built around the structure of ISO 9001 which is a standard for Quality Management Systems Requirements applied across all industry settings other than medical device companies.

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medical device quality control and quality assurance

5 FAQs about Medical Device Quality Assurance vs Quality Control

Blog, Client Questions, Quality Assurance / David Small

Quality Assurance and Quality Control are both very important factors in the Medical Device Industry. But what is Quality Assurance and Quality Control and how do they differ?

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Quality Assurance

Medical Device Cleaning Validation

Medical Device Labelling

Notified Bodies

Understanding the core elements of Quality Management Systems

5 Differences Between ISO 13485 & FDAs Medical Device QSR

What is ISO 13485?

Quality Assurance & Quality Control

ISO 13485 Standard – Quality Management System

5 FAQs about Medical Device Quality Assurance vs Quality Control

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