This month marks the first-year anniversary of Qserve’s Regulatory Intelligence tool: InSight. The tool literally does what its title suggests: it provides insight into regulatory developments in over 80 countries, with summaries and - for more critical changes - impact assessment that indicate the critical impact for manufacturers and/or other stakeholders. Content moderation is done by a team of dedicated regulatory, quality and clinical consultants from the various teams within Qserve.
Qserve’s project lead on the tool Olena Hoi reflects:
“Launching InSight was no small feat. In the competitive landscape of MedTech regulatory intelligence, standing out requires more than just technology - it demands deep expertise and a clear purpose. From the outset, I believed in the value we could deliver by embedding the knowledge and experience of Qserve consultants into a platform that truly serves the medical device and IVD sectors”.
Sponsor from the Board of Qserve, Martin de Bruin, adds that “from 10 countries to 80 is a major achievement. We were able not to add countries only however the backbone of the system needs to grow as well, and not to forget the moderation. Adding new sources is nice however on the other hand it creates more documents that need to be moderated and maintained.”
One of the key moderators, Bianca Lutters, Director Knowledge Management, Head of Clinical Affairs & Principal Consultant, continues: “Starting with moderation in InSight has been an opportunity to be in the middle of the developments of regulatory requirements. Initially, it was a limited number of countries, but it has increased over time to cover the most important countries for manufacturers in this year. With the increase in countries, but also sources per country, the work to review and include relevant information in InSight for each of the records has also significantly increased over the year. It made me appreciate how much work a good regulatory intelligence process is for a manufacturer!“
Olena adds further detail:
“While many tools exist in the market, the real challenge lies in curating and delivering relevant, actionable information. That is where InSight makes a difference. What began as a simple tracker for regulatory changes in the top 10 markets has evolved into a robust platform covering over 80 countries across key regions. We have integrated FDA-recognized standards, added CEN/CENELEC content, and are now developing a dedicated section for ISO standards”.
The launching customers have jointly supported the step-wise increase and finetuning of the tool, and their indications on how the current tool is supporting their regulatory intelligence requirements are very positive. A series of additional manufacturers, in medical devices as well as in IVDs, are currently evaluating the tool, and demand is growing.
Martin, heading up the sales and marketing teams, indicates that “we see traction in the market as customers do want a simple system that checks changes in regulations and standards. That is exactly what InSight does. It developed into a tool that is easy accessible as stand alone and provides a simple notification on changes in regulations in 80+ countries as well as changes in standards for US, EU, ISO. Every customer we speak is enthusiastic, we just need to find a way to make it aware to the broader public.”
Olena agrees. “InSight has grown from an internal instrument into a standalone service we proudly offer to our clients - backed not only by data but by the regulatory expertise that defines Qserve.”
Next steps
One of the next steps is not only to build additional countries, and expanding the scope to adjacent legislations, the further improvements will also start benefitting from the reflections of the global team of Qserve consultants. As Martin indicates: “I would like to see increased involvement from our consultants as they are the ones that have daily contact with our customers and are able to provide valuable feedback.”
“Was the path straightforward?”, Olena reflects. “Certainly not. Becoming an IT product owner overnight came with its own learning curve. But today, I am proud of what we have built: a tool that keeps us ahead of regulatory developments and helps simplify the compliance journey for our customers.”
We are proud and happy to be able to celebrate the first year of InSight. A year in which it developed from an internal tool into a robust, mature system, now ready to support widespread adoption across the global MedTech industry. As Olena put words to our joint view, she indicates that InSight is more than just a platform with updates - it’s a reflection of our commitment to making regulatory intelligence accessible, reliable, and impactful.
InSight is available for you, ready to be fine-tuned to your needs!
Gert Bos