You fight against COVID-19?

We support you all the regulatory way.


You develop or manufacture COVID-19 medical devices or in-vitro diagnostics?

We develop your regulatory strategy.

Quality management system | Technical Documentation | Worldwide market access


Worldwide, the MedTech and IVD industry is increasingly being subjected to regulation – throughout the entire product life cycle. Regulation turns into success when sound strategic decisions meet practical experience. AstraCon offers both.

Your employee resources - limited?
We Supplement your team.

Specialists during work peaks | interim replacement for maternity and parental leaves | search for experts worldwide

Your documentation - burdensome?
WE PROVIDE HANDS-ON HELP.

Update your technical documentations to the new MDR or IVDR regulations | PMS |
Risk management | Biocompatibility | State-of the-art clinical evaluation


“Technology is

the answer,

but what was

the question?”

Cedric Price

YOUR PRODUCT PIPELINE – SLOW?

WE ARE YOUR PARTNER FOR REGULATORY STRATEGY.

Regulatory input for new product development | Early risk analysis | Communication with authorities and investors

YOUR QUALITY MANAGEMENT SYSTEM – OUTDATED? 
WE HELP YOU WITH QMS MODERNIZATION.

State-of-the-art QM-system | Person responsible for regulatory compliance (MDR/IVDR) | Train your team members |
Manage external audits | Perform internal audits


“Ideas are

worthless.

Execution is

everything.”

Scott Adams


Together we will find solutions for your individual questions and requirements.