The Munich-based startup uses AI-driven automation to cut documentation time and cost by up to 60 per cent, accelerating medical device approvals across Europe.

Across Europe, medtech companies are facing unprecedented regulatory pressure. 70 per cent of manufacturers report significant struggles with regulatory burden, and implementing new medical regulatory requirements alone is estimated to cost the industry €12 billion.

Obtaining market approval for a medical device today takes an average of 5 years and costs companies more than €4 million in compliance and documentation labour — a structural bottleneck slowing innovation across the entire sector.

CertHub’s AI-first approach directly addresses this inefficiency: proven customer success have shown that manufacturers save up...

The Munich-based startup uses AI-driven automation to cut documentation time and cost by up to 60 per cent, accelerating medical device approvals across Europe.

Across Europe, medtech companies are facing unprecedented regulatory pressure. 70 per cent of manufacturers report significant struggles with regulatory burden, and implementing new medical regulatory requirements alone is estimated to cost the industry €12 billion.

Obtaining market approval for a medical device today takes an average of 5 years and costs companies more than €4 million in compliance and documentation labour — a structural bottleneck slowing innovation across the entire sector.

CertHub’s AI-first approach directly addresses this inefficiency: proven customer success have shown that manufacturers save up to 60 per cent on documentation time and cost, creating a €2.4 million saving potential per certification cycle.