TURNING REGULATION INTO SUCCESS
We offer strategic regulatory consulting and quality management services for IVD and medical device companies.
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
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YOUR QUALITY MANAGEMENT SYSTEM – OUTDATED?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
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