STRATEGIC REGULATORY STEWARDSHIP

The balance between safety and product availability is key to precisely understand what legal and regulatory framework applies to clinical decision systems. Not all clinical software qualifies as medical device and such regulatory uncertainty creates a “grey area” which is one of the key obstacles for software development and investment in this area.

Lynkeus’ HTA and Risk Analysis Service focuses on the regulatory and economic impact of each target CDSS, with the goal of reducing regulatory risks and maximizing the commercial value of the product. Lynkeus has developed a proprietary assessment methodology, TrueRC®, to address regulatory profile and planning for the European and American markets.

This strategic regulatory stewardship service includes:

• indications of use and limitations (to assist the Lab/software producer in defining the purpose and validation settings of the software, required to appropriately positioning it with regard to applicable rules and classification);
• clearance and conformity assessment procedures (accordingly to the risk classification and procedures related to the destination market, if subject to USA or EU regulation or both);
• economic impact of the regulatory setting (taking also into account if pre-market review and clearance or even approval by authorization bodies may be required or pre-clinical and clinical trials are needed).