Testing

Testing for medcial products is required as evidence for CE certification, or for devices to be covered by German health insurance funds. Requirements can be very strict, so why not make the most of our expertise?

We will be happy to organise your testing and guide you through the process.

Topics

Electromagnetic compatibility (EMC)

Electrical equipment and systems for medical use must meet the requirements of the EN 60601 family of standards. There is a huge number of testing facilities of all sizes, with different levels of accreditation recognised at international or national level. We will work with you to find the right testing facility for your product and your company; a reliable, fully-qualified organisation that will treat you as an equal partner.

We can organise the whole testing process  for EMC from start to finish, as well as providing insights from our many years of specialist and testing expertise.

Mechanical Safety

At least one mechanical feature has to be evidenced for almost all medical devices. Generally speaking, evidence must be submitted demonstrating the product’s build quality, functional suitability and performance. We can advise you about the requirements and standards to which your medical device is subject, and which testing facilities are best placed to test it.

Our experts can organise the whole testing process from start to finish, as well as providing insights from our years of specialist and testing expertise.

Biological Safety

For medical devices that will be in direct or indirect contact with the body, evidence must be provided of biocompatibility, i.e. that the product has no negative effects on live tissue. This evidence must normally be in line with the EN ISO 10993 family of standards. Such devices also have to undergo a range of additional tests including contact classification and material characterisation. We can advise you about the requirements and standards to which your product is subject, and which testing facilities are best placed to test it.

Our experts can organise the whole testing process from start to finish, as well as providing insights from our years of specialist and testing expertise.

Functional Safety

There are a number of different aspects to functional safety for medical devices.

We can advise you about the requirements and standards to which your product is subject, and which testing facility is best placed to test it.

Ageing

The lifespan of every medical device is limited by definition. However, all devices must remain safe to use up to the point at which they are disposed of. As part of the certification and approval process, you must demonstrate that you are in control of the product’s entire life cycle, from initial manufacturing  to the end of its useful life. We can advise you about how best to do this and which testing facilities will be able to provide you with the evidence you need.

We can organise the whole testing process from start to finish, as well as providing insights from our many years of specialist and testing expertise.

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