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YOUR QUALITY MANAGEMENT SYSTEM – OUTDATED?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