Medical devices & welfare

DELTA provides an overview of the regulatory requirements for medical devices and outlines the initiatives that shall be taken before your medical device can be sent to the market.

The market for medical devices covers a wide range of different types of goods, from heart rate monitors and scanners to electronic patient records. The introduction of new technologies combined with the healthcare system’s demand for intelligent solutions generates an increasing volume of medical devices, which is introduced to the marked all over the world. The work within this area is exciting but nevertheless full of pitfalls, because it is a strongly regulated market.

To succeed in developing equipment for the global market requires that you have a well-documented and well-described quality assurance process.

DELTA helps you move through the process to product approval – regardless of whether you are new to the market or already have knowledge about the development, production, approval, and marketing of medtech products. We provide you with answers to questions like:

Which regulatory requirements is my medical device subject to?

Which markets can I get access to and which documentation is necessary?

Which technologies (e.g. wireless or senor technology) can I include in my medical device?

Important directives, standards and rule parts

Directive 93/42/EEC

ISO 14971

ISO 13485

EN 60601-1

EN 60601-1-2

EN 60601-1-6

EN 60601-1-11

EN 60601-2-x

IEC 60601-1

IEC 60601-1-2

IEC 60601-1-6

IEC 60601-1-11

IEC 60601-2-x

CFR 21 (FDA)

Relevant services

EMC tests

Climatical tests

Mechanical tests

Robustness tests

Accelerated life tests

Wireless tests

Process and quality management

Innovation

Approval Management

Troubleshooting

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