Basic info
Industry
business consulting and services
Sectors
Consulting
Qultek can provide PRRC services for startup and small medical device manufactures Article 15(c) of the European MDR (2017/745) and the IVDR (2017/746)
Staffing Agency
Web Development
requires that the manufacturer shall have a person that will be responsible for regulatory compliance (PRRC) also has the requirement and the explicit responsibility to ensure that all postmarket surveillance and obligations are met in accordance with Article 10(10). The recent June 2019 EU PRRC Guidance Document (MDCG 2019-7)4 further expands on the required education and experience the PRRC should have – with the two optional requirements being:
Recruiting
Date founded
2007