|
Software Regulatory Compliance
|
|
A number of adverse events related to medical device software has led to a
growing trend in recent years for manufacturer’s software development processes to come under
intense scrutiny by regulatory bodies. This has been underpinned by the requirements of the new EU MDR/IVDR and FDA
guidelines for software applications aimed at the European/American markets which directly affect software with a medical purpose. Manufacturers must consider not only
software in their target devices, but also software used in the manufacture of the devices;
software used in quality systems (including electronic records); software used in accessories
to the device and off-the-shelf (SOUP) software. |
|
C-Path have experience in taking a wide variety of medical software products and applications, with safety classifications and levels of concern ranging from the lowest to highest risk, from concept to market. We can assist in the preparation, implementation and submission of software for regulatory approval including UKCA, CE (Compliance with EU MDR/IVDR) and FDA (DeNovo, 510(k) and PMA). |
|
From start-up companies with little or no experience in the medical device sector, to
established companies needing additional assistance in getting a device to
market (or increase market presence), C-Path can provide valuable hands-on development and regulatory compliance skills, gained from over 24 years experience with a wide range of medical products and applications, that make a positive contribution to your development project and subsequent product pre-market approval. |
|
We can assist in:
Planning , implementation and documentation of Technical Files/Dossiers; Design History
Files; of Regulatory Submission files. |
|