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What we do great

We offer Regulatory and Quality Management System (QMS) consulting services.

 

Our approach is to design, implement and maintain custom-made integrated QMS models in compliance with the local and essential global regulations.    

 

Our service includes creation, update, implementation, and maintenance, verification of effectiveness of the requested sub-systems to build up an integrated QMS, alongside training and auditing.

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The services assure compliance with:

The new EU MEDICAL DEVICE REGULATION (MDR)

MDSAP PROGRAM

Quality System under EN ISO 13485, US FDA QSR - GMP

Design Control Under EN ISO 13485  &  21 CFR PART 820

Application of risk management to medical devices

Process Validation including software – Test method validation – clean room validation

The Literature Route for Clinical Evaluations

POST-Market SURVEILLANCE AND VIGILANCE

Good Manufacturing Practice (cGMP)

The new EU IVD REGULATION (IVDR)

CLINICAL EVIDENCE -- IVDR

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