Medical Device Pre-launch

Medical Device Life Cycle following the Plan, Do, Check, Action model. Used by patient guard to explain medical device design and development life cycle which start with medical device regulations, then standards, then design inputs, then risk management, then design outputs, prototypes, design verification and validation, manufacturing specifications and finally design history, before the cycle starts again at regulations.

Medical Device Design and Development

Blog, Guides and Advice, Medical Device Pre-launch /

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. 

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Image of a file with a cog and lines above it representing text. The cog represents technical information. The image is used by patient guard limited to discuss medical device technical files (EU 2017/745).

How to Structure a Medical Device Technical File

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

A medical device technical file is a concise set of documents created by a manufacturer to explain the performance and safety of a particular Medical Device in a clear, well-organized, easily searchable, and unambiguous manner.

In order to prove compliance with the general safety and performance criteria of the legislation, the manufacturer must have – and keep up-to-date – this technical documentation, regardless of  medical device class.

How to Structure a Medical Device Technical File Read More »

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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