Quality + Regulatory

We need to talk about Brexit and medical devices

We need to talk about Brexit and medical devices

On 31 January 2020, the UK left the European Union. For the rest of the year at least, there's a transition period during which existing arrangements apply. You may well be wondering what this all means for you, now and afterwards. Here's the situation in a nutshell:...

Ensuring Your Medical Device Is Both Safe and Effective

Ensuring Your Medical Device Is Both Safe and Effective

https://youtu.be/Plwrhzc9wYE It’s a major part of getting your medical device approved. It’s also vital to show that your device is safe and effective in use. Clinical Evaluation requirements have become larger and more complex, with the advent of the Medical Device...

How To Get a CE Mark For Your Medical Device

How To Get a CE Mark For Your Medical Device

https://youtu.be/MDH6FC3P0LI As you’re watching this video, it’s safe to say that you’re at least curious about how to get your medical device approved for sale in the European Union. Still with me? Then we’ll begin.   If you had a sense of what you needed to do,...

How To Manage a Medical Device Project

How To Manage a Medical Device Project

https://youtu.be/eq4JUA0dHYY It’s a complex, challenging thing, developing a medical device. And it’s littered with opportunities for pain. Opportunities that good project management helps minimise. But, what does good look like? If you had a sense of what you needed...

A route to Regulatory Compliance: Part 2 – Quality Management

A route to Regulatory Compliance: Part 2 – Quality Management

https://youtu.be/nZQkE7wxD2c Compliance with regulations and quality requirements is a key component of success when you’re developing a medical device. If you had a good feel for what you need to take care of for this, what would you do?   In this bite-size...

A Route to Regulatory Compliance: Part 1: Design Controls

A Route to Regulatory Compliance: Part 1: Design Controls

https://youtu.be/0CPgz39sCso Developing a medical device is a complex business, and compliance with regulations and quality requirements is a key component of success.   How would it be, if you had a clear picture of what you need to take care of for these...

4 W’s of Design Review

4 W’s of Design Review

https://youtu.be/0ivYXoeOfHY Developing a medical device is a complex business, with many opportunities to experience pain. And one of those moments that keeps cropping up is Design Reviews – they’re a requirement for the US, covered in ISO 13485 and you know what?...

4 steps to create a medical device

4 steps to create a medical device

https://youtu.be/9whDcxJXSsI Having watched other videos in this series, you’ll appreciate that developing a medical device is a complex business, with many opportunities to experience pain. We’re here to help you avoid as many of those painful moments as we can. If...

How to make sure your project doesn’t fail

How to make sure your project doesn’t fail

https://youtu.be/y8r-pZXb3NE You’ll probably remember our discussion about 5 key things that successful device development projects take care of, to minimise the risk of failure and the harm and expense that results? I’d like to share with you an approach to looking...

Failure is expensive, very expensive!

Failure is expensive, very expensive!

https://youtu.be/WVjnX8D2DeU Failure is expensive, very expensive And it gets even more expensive when you’re developing a medical device. Like me, you’d probably like to avoid the pitfalls where you can, avoid the pain. Abut 10 years ago, being naturally curious...

ISO 13485:2016 – time has run out!

ISO 13485:2016 – time has run out!

You'll probably recall me mentioning ISO 13485, and its relevance to ensuring that you don't fail? If you've reached the conclusion that it would be advantageous to show customers, regulators or investors that you're working in an appropriate way, then you'll see the...

Another week, another funding opportunity

Another week, another funding opportunity

Hot on the heels of last week’s article, there’s a further opportunity to get some funding to support your development project. This time, the criteria are slightly different, but rest assured, we can walk you through the process. SMEs in West Midlands, Yorkshire and...