Regulatory Compliance

With over 24 years experience in medical device product development for a wide range of applications, including software used in: oncology, gynecology, ophthalmology, cardiology and in-vitro diagnostics; C-Path provides consultancy, training and support in the use and application of international regulations, standards and guidance for medical device software applied throughout all phases of the product life cycle - from initial concept to market release, post-market surveillance and retirement. We can support you in preparing the required documentation and evidence necessary for product/device regulatory approvals to gain access worldwide markets; including UKCA, EU CE (MDR/IVDR) and FDA (510(k)/PMA/DeNovo/CLIA).

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From start-up companies with little or no experience in the medical device sector, to established companies needing additional assistance in getting their software device to market (or increase market presence), we can support you in planning, implementing and documenting product Design History Files; Technical Files/Design Dossiers and associated regulatory compliance data required for worldwide market approval.

We can advise and provide support/training on the regulatory requirements for software:

  • stand-alone/used as a medical device (SaMD)
  • embedded or part of a medical device (SiMD)
  • used as an accessory to a medical devices
  • considered off-the-shelf (SOUP)
  • in quality management systems
  • in the manufacture/test of medical devices;