Testing medical devices to home healthcare standards Understand the compliance requirements
With over 10 years of experience, Alex supports global medical device manufacturers with navigating the complexities of the international medical regulatory landscape, specializing in compliance, particularly in product safety and IEC 60950-1.
Download our whitepaper, ‘Testing Medical Devices to Home Healthcare Standards’, where Element’s medical device expert, Alex Brumpton, covers the topic of home healthcare device compliance, as well as the challenges manufacturers face and compliance considerations to overcome them.
As home healthcare equipment becomes increasingly more advanced, more hospitals and other medical facilities continue to transition patient care to home settings. It’s crucial for manufacturers developing home healthcare devices to understand their testing and compliance requirements, to simplify their compliance journey and speed up their time to market.
Complex global regulations
Developing products for use in potentially hazardous locations is complex, with different countries and regions having variations of both mandatory and non-mandatory legislation. A lack of clear regulatory understanding and planning can lead to longer development times and costly redesigns or testing if it isn’t designed for global compliance.
Product and Patient Safety
It’s crucial manufacturers are clear on their products intended end markets and the use cases their product is designed for.
Accelerate Time to Market
A product’s compliance journey can be a time consuming and challenging process, with many hurdles and variations to compliance. It’s crucial that manufacturers understand their routes to market to reduce the risk of costly delays or redesigns.
Download our Whitepaper to get:
- Expert analysis of the global home healthcare equipment compliance requirements
- Breakdown of the challenges home healthcare manufacturers face
- Considerations to overcome the compliance challenges
Learn more about:
- Introduction to home healthcare equipment
- Regulatory frameworks for medical devices
- Compliance for home healthcare devices
- Challenges in testing medical devices in home healthcare
- Considerations for overcoming compliance challenges
- How Element can help
Complete the form below to read the whitepaper.
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