Regulatory compliance for medical devices is a minefield. There are dozens of harmonized standards and technical requirements that are constantly evolving. This makes regulatory compliance an ever-moving target, difficult to keep up with.
We keep our hands on the pulse when it comes to medical regulations, compliance testing standards, and best practices in risk management. This enables us to work closely with Medtech companies of all sizes; from startups seeking support in taking their first product to market, to large enterprises that are in need of an additional pair of hands with an urgent project.
Company’s Keywords:
medical device regulation, software as a medical device, medical device, regulatory compliance
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medical devices
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