Medical Device Post-launch 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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Post Market Clinical Follow-up – Medical Devices

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

Post Market Clinical Follow-up of medical devices is an important part of Post Market Surveillance. It is the process of monitoring devices in the real world environment.

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medical device post market surveillance.

Post Market Surveillance – Medical Devices

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

Post-market surveillance (PMS) is a pivotal aspect that governs the continued monitoring and assessment of medical devices after they have entered the market. Across the EU, UK, and USA, distinct regulatory frameworks shape PMS protocols, fostering safety, and innovation simultaneously.

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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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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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Medical Device Post-launch

Medical Device Cleaning Validation

Medical Device Labelling

Notified Bodies

Electrical Safety in Medical Devices

Medical Device Sterilization

Software as a Medical Device (SaMD)

Post Market Clinical Follow-up – Medical Devices

Post Market Surveillance – Medical Devices

Medical Device Clinical Evaluation

Is My Product a Medical Device?

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