Profess Medical Consultancy B.V. can develop for hospitals, institutions, pharma companies, medical device companies and companies in the food industry digitalized quality systems for clinical research purposes that are compliant with all applicable rules and regulations in the European Union and the United States of America. We can also transfer such quality systems to an ISO 9001: 2015 compliant system.
If you wish to build a compliant quality system for your research work, then invite us to discuss the possibilities.
As examples we refer to our generic SOP-Z system for investigator initiated drug research in the Netherlands. SOP-H is an example of a quality system for investigator initiated drug research in countries in the European Union. And SOP-M is specialized for clinical investigations with medical devices in countries in the European Union. These systems are examples for your quality system that we specify to your specific organization.
A set of standard operating procedures required to conduct investigator-initiated (non-commercial) studies in Europe in compliance with current regulatory requirements. The quality system is written in English language.
For clinical investigations with medical devices we have built SOP-M Quality System