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.
Medical Device Labelling Read More »
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.
The General Safety and Performance Requirements (GSPRs) are detailed in the EU Medical Device Regulations (MDR) EU 2017/745 and detail what a manufacturer must show to prove that the medical devices they sell are safe and perform as intended.
Understanding EU MDR GSPRs Read More »
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.
Electrical Safety in Medical Devices Read More »
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.
Medical Device Sterilization Read More »
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.
Software as a Medical Device (SaMD) Read More »
Planning for the design and development of a medical device is a requirement of regulatory systems. All manufacturers of Medical Devices are required to maintain a Quality Management System, in the USA this is determined under the CFR Title 21 part 820. Within the European Union, it is placed within demonstrating certificated compliance with international standard EN ISO 13485. The USA has recently indicated that they will also use the ISO 13485 standard for the requirements of manufacturers being compliant for QMS purposes.
Medical Device Design and Development Read More »
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.
Post Market Clinical Follow-up – Medical Devices Read More »
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.
Post Market Surveillance – Medical Devices Read More »
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.
Medical Device Clinical Evaluation Read More »
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