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Health Care Regulatory Explorer

Your personal guide to the Medical Device Regulations

In a time of unprecedented challenges in the healthcare sector, innovative health care technology saves lives everyday.

However, new medical devices face a long and expensive route to market in a complex and changing regulatory environment.

Find out how we can help
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All product types

Medical Device Software

Software

Software as a Medical Device (SaMD) is a growing part of the medical device sector. 

Consumer products

Wearables

Wearables are the latest trend in consumer health products. Some wearables are also medical devices.

In Vitro or In Vivo

Diagnostics

Diagnostics are a critical part of health care. In Vitro Diagnostics have a separate set of rules.

Drugs and medicines

Borderlines

Special rules apply to combination products that involve a drug, biologic or medicine.

International regulations

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