Risk Management

5 Things You Need To Know About Medical Device Risk Management

5 Things You Need To Know About Medical Device Risk Management

It may have escaped your notice, in the run up to Christmas and year end, that there have been some substantial changes to the way we manage risks when we develop or manufacture medical devices. As you read that sentence, you may have sighed. It’s an understandable...

Balancing Risk and Reward

Balancing Risk and Reward

https://youtu.be/XaCdbrgN4QY It doesn’t matter how sexy, high tech or innovative your medical device is. You must, and regulatory authorities demand this, understand and mitigate risks for the user if you want to get approval to sell your product.   If you had a...

So, you want the NHS to buy your medical device?

So, you want the NHS to buy your medical device?

https://youtu.be/P9FgWVOCMe0 In many of the conversations we’re having this year, one of the top things people tell us that they struggle with is the challenge of getting their medical device into the NHS. Perhaps that looks familiar, strikes a chord, feels like...

Getting Your Design Right

Getting Your Design Right

https://youtu.be/yYofOOBrc_s Coming up with a design for your medical device that can be manufactured, assembled at a low cost, whilst ensuring it does what users need it to do, safely and repeatedly, is one of the big challenges you’ll need to overcome If you could...

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 navigate complexities of medical device development

How to navigate complexities of medical device development

https://youtu.be/pHmvnJoRlIQ It’s a complex business, developing an idea into a medical device. And it’s complicated by the myriad of important things you need to address, to get approval to sell your product in markets around the world. So, it’s understandable that...

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...

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...

Medical Device Risk Management

Medical Device Risk Management

Risk occurs in all our lives, it’s a part of our everyday living. To minimise the threats from risk and maximise their potential we need to manage our risks; this equally applies to the field of medical device development.  By implementing a risk management process,...