Medical Device Validation 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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Electrical Safety in Medical Devices

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

Electrical safety in medical devices is important to ensure that users of electronic medical device equipment are not subject to electrical risks. Medical Device manufacturers must ensure that their electronic devices are safe and that any risks are as low as possible.

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Medical Device Sterilization

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

Medical Device Sterilization is a key aspect of ensuring certain Medical Devices are safe and effective. Sterilization ensures that the medical device is free from microorganisms before they are used on patients. Reducing the risk of infections.

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Software as a Medical Device (SaMD)

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

Software as a Medical Device (SaMD) has revolutionised the healthcare industry. From AI helping with medical image scanning to software being used in apps, to help with clinical decision making. Understanding how SaMD is regulated is critical to its success when being launched as a product.

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Medical Device Clinical Evaluation

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

Medical device clinical evaluation is an essential part of regulatory compliance. Clinical Evaluation is a review of all the data that has been generated by the medical device manufacturer; pre-clinical, clinical and post market. The review of this data is performed to assess that the benefits of using the medical device outweigh the risks associated with using the medical device within the devices clinical intended purpose.

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5 test tubes with green, yellow, red, purple and blue coloured liquid to make a rainbow. Used by patient guard to represent biological evaluation services.

The Biological Evaluation of Medical Devices

Blog, EU Regulations, Guides and Advice, Medical Device Validation, Standards, UK Regulations, USA Regulations / David Small

In healthcare, ensuring the safety and efficacy of medical devices is paramount. Patients rely on these devices for diagnosis, treatment, and improved quality of life. Biological evaluation plays a pivotal role in determining the biological safety of these devices. Governed by international standards, most notably the ISO 10993 series, biological evaluation involves a thorough assessment of a device’s interaction with living tissues. This blog delves into the importance of biological evaluation, highlighting the critical biological endpoints outlined in ISO 10993, the significance of a robust biological evaluation plan, and the crucial role of qualified experts in this process.

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Is My Product a Medical Device?

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

When developing a new and exciting product it can be hard to know if it might fall under specific regulations. This is usually the case with medical devices. The medical device industry is highly regulated worldwide. These regulations have specific criteria that determines if a product falls under the definition of a medical device. Therefore it is really important to evaluate your product to see if it might be in the scope of these medical device definitions for the regulation of the countries in which you wish to sell the product in.

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Patient Guard Medical Device and IVD Regulatory and Quality Assurance consultancy

Medical Device Consultancy Companies

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

A medical device consultancy is a firm that offers specialized services for companies involved in the development, manufacturing, and marketing of medical devices. These consultancies typically have teams of experts who provide a wide range of services, from regulatory strategy to product development, quality management systems (QMS), and market access.

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Medical Device Validation

Medical Device Cleaning Validation

Medical Device Labelling

Notified Bodies

Electrical Safety in Medical Devices

Medical Device Sterilization

Software as a Medical Device (SaMD)

Medical Device Clinical Evaluation

The Biological Evaluation of Medical Devices

Is My Product a Medical Device?

Medical Device Consultancy Companies

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