See article

The QA to the Sponsor’s QA: Why the Legal Representative Should be Separate from the CRO

The role of the legal representative for clinical studies – both in pharmaceuticals and now in medical devices under the EU Medical Devices Regulation (MDR) – might be described as quality assurance of the sponsor’s QA role. In future, under the new EU Clinical Trials Regulation (CTR) and MDR, the legal representative will be responsible […]

See article

Why “Ensuring” the Sponsor’s Compliance is Not the Right Role for CROs

The Medical Devices Regulation will bring massive and rapid change to the industry. Not only must companies adjust to new clinical investigation requirements, but they will suddenly find themselves in need of a number of new experts. Medical device companies wanting to run clinical investigations of their products in Europe will need a qualified person […]