Just Three UK Medical Device Notified Bodies Left As LRQA Pulls Out
Medtech companies that have been loyal to LRQA could find themselves at a serious competitive disadvantage as the organization pulls out as a notified body for medical devices and IVDs, putting the whole medtech regulatory system under increased stress.
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Corin has transformed from a niche UK hip resurfacing company into an innovative global player in orthopedics with a portfolio that includes robotics. UK branch managing director Paul Gibbons explained the group’s approach to business during COVID-19 and its culture of innovation.
Corin has transformed from a niche UK hip resurfacing company into an innovative global player in orthopedics with a portfolio that includes robotics. UK managing director Paul Gibbons explained the group’s approach to business during COVID-19, and its culture of innovation.
'Burn Them Out, Turn Them Over': Add Auditor Exhaustion, 'Boutique' Approach To The List Of Notified Body Challenges
From not enough notified bodies and auditors, to a slew of new or updated international standards and regulations coming into force, the medtech industry is facing a number of NB challenges – and now they can add auditor burnout as a concern. "Because some of these notified bodies have such huge demand, they're burning people out really fast," industry expert Kim Trautman says, noting that device-makers can expect to see "boutique" notified bodies popping up over the coming decade. Also: Johnson & Johnson's regulatory director explains how the dearth of notified bodies and auditors is affecting the global medical products giant.