Just Three UK Medical Device Notified Bodies Left As LRQA Pulls Out
Executive Summary
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.
You may also be interested in...
Data And Connected Insight Will Take Corin Beyond COVID-19
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.
Interview: Data And Connected Insight In Arthroplasty Will Take Corin Beyond COVID
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.