What regulatory software does a small medical device company need?

The work an eQMS is not built around

A quality system is organised around processes: procedures, records and the controls that keep them in order. Regulatory affairs is organised around products and markets: this device, in this market, held by this party, due on this date. When that work lives in a QMS document library or a spreadsheet, the dates and the dependencies are the first thing to go.

• A pathway per product per market, broken into the work that gets you there
• Registrations and licences per market, with the holder and the next recurring date
• Post-market surveillance plans and reports that start on time, not when someone remembers
• Change assessments with the reasoning kept, so the decision trail exists before anyone asks
• Correspondence with notified bodies, authorities and your representatives in each market

What to look for in regulatory operations software

For a team of one to five people, the test is whether the tool removes remembering. Look for one product record shared by every market, dates the system works out and raises before they fall due, evidence attached to the obligation it discharges, and an audit trail you did not have to build by hand. It should not ask you to move your quality system.

When spreadsheets are still enough

One product, one market, no submission in flight: a well-kept spreadsheet and a calendar will do. The tipping point is usually the second market or the first representative. From then on the same device carries different holders, identifiers and recurring dates in each jurisdiction, and the spreadsheet becomes the single point of failure.