OUR CLIENTELE

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 for regulatory projects to relieve your team during work peaks | interim replacement for maternity and parental leaves | search for experts worldwide

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

Reconstruction of your technical documentations to the new MDR or IVDR | PMS reports, PS plans, PSUR and SSCP | 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.


Due diligence for product acquisitions | 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YOUR QUALITY MANAGEMENT SYSTEM – OUTDATED?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) | train your team members | manage external audits | perform internal audits


“Ideas are

worthless.

Execution is

everything.”

Scott Adams