As medical device suppliers respond to rising regulatory scrutiny, they can expedite their preparations by looking at the lessons learned in pharma around product data and associated content management. Here, Celegence’s Sonia Veluchamy distils some best practices.

Life sciences Regulatory Affairs teams and their colleagues in Quality and Safety face already overwhelming workloads, which are compounded each year by evolving health authority (HA) expectations around detailed product information capture, monitoring and reporting. While the pharma industry is steeped in experience of this now, the medical device sector is playing catchup.

In pharma, a steady progression of HA requirements has triggered extensive investment over the last two decades – in IT systems, data standards and data governance preparations, and optimised data and content management. Most recently this has been towards adherence with ISO IDMP, the international framework designed to describe medicinal products using agreed vocabularies.

The wider goal for companies as they adapt to regulators’ evolving needs is to achieve this in an affordable and futureproof way with benefits to their own operational efficiency. In pharma, this has prompted a series of strategic technology investments to streamline regulatory processes and ensure that patients can continue to access the drugs they need.