Expertises, 13485, 9001, MDSAP, CE, CE mark, MDD, 93/42, European Directive

QB expertise covers both active and non active medical devices and the entire product lifecycle, from the product conception through manufacturing, market release, servicing and disposal.

The above is combined with an extended knowledge of Quality Systems according to ISO9001, ISO13485, ISO15378, FDA 21CFR Code 820 and a deep knowledge of the requirements from the Medical Device Directive 93/42, the Medical Device Regulation 2017/745, the IVD Regulation, the Canadian MDR and the Medical Device Single Audit Program.

QB also offers a wide experience in CE marking of medical device and IVDs, process outsourcing, subcontracting, OBL/OEM relationships, competent authorities interfacing and a strick and durable collaboration with the major European Notified Bodies.