Medical Device Post-launch

medical device clinical evaluation.

Medical Device Clinical Evaluation

Leave a Comment / Blog, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, UK Regulations /

All Medical Devices that are placed on the market in the EU and the UK must undergo Clinical Evaluation. 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?

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 /

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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Understanding IEC 62304: A Guide to Medical Device Software

Blog, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Standards /

In the ever-evolving landscape of healthcare technology, medical device software plays a pivotal role in patient care. To ensure the reliability, safety, and effectiveness of these software-driven devices, regulatory standards are in place. One such crucial standard is the IEC 62304. In this blog, we will delve into the intricacies of IEC 62304, exploring its significance, key concepts, and its impact on the development of medical device software.

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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 /

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.

What is ISO 13485? Read More »

medical device post market surveillance.

Post Market Surveillance – Medical Devices

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

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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Blood Pressure Cuff, scissors, syringe, stethoscope placed on a white background - Represents medical devices - image used by patient guard to represent subjects relating to medical device and IVD regulatory affairs and Quality Assurance.

Medical Device Start-up – is not applying a regulatory strategy early on costing more in the long run?

Blog, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, UK Regulations, USA Regulations /

Starting a medical device company can be a stressful time, what with design and development activities, finding funding, ensuring you don’t run out of capital etc.

One very important area that is often not considered early enough is the regulatory side. Many medical device startup companies think that the regulatory activities don’t begin until the device has been developed and they often don’t realise the cost involved in ensuring that the medical device meets the safety requirements of the medical device regulations globally

Medical Device Start-up – is not applying a regulatory strategy early on costing more in the long run? Read More »

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