Risk Management is the fundamental cornerstone on which global regulations are built.

From device classification to post-market surveillance and obsolescence, the determination and on-going management of device risk is the underlying driver that guides manufacturer’s and economic operator’s product strategies, organisational structure and activities.

Our knowledge of and participation in the development of multiple horizontal and vertical international standards, that mitigate device risk, as well as the core risk management standard, ISO 14971, makes ARC Regulatory your ideal partner of choice for Risk Management of your medical device portfolio:

  1. We develop and implement integrated risk management strategies that are fully compliant with international requirements
  2. We ensure that the benefit of the device you bring to market truly outweighs the risks, protecting your business reputation in the event of post-market issues
  3. We train development teams on gold-standard application of risk management, and associated tools and techniques, ensuring accurate reflection of the risk of your medical device


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