Hearing Aid Manufacturer Strives for MDR Compliance

 
INDUSTRY
Medical Device Manufacturing
SERVICES
Regulatory Affairs
SKILLS
European Medical Device Regulations (MDR)
Three expert consultants with specific EU MDR compliance expertise provided.
The Challenge

A medical device manufacturer focused on hearing aids was in the process of a global MDSAP implementation and rollout. During this initial project, their need for an MDR lead consultant became apparent. The client had to be certain they were partnering with the right MDR expert to guide the company to compliance within the deadlines. This complex initiative would involve building the new MDR guidelines into the different divisions of the company — from research and development to manufacturing and engineering with equipment suppliers, labeling and packaging, technical files, and CERs. 

The Solution

Because of our previous successful partnership with the client in various projects including FDA inspection readiness and MDSAP, they trusted Oxford Global Resources to select the right talent to lead them on the path towards MDR compliance. The consultants needed to have an understanding of MDR requirements for active electronic devices falling within Class I and IIa. In addition, it was essential the consultants had an understanding of standards such as IEC 60601 and IEC 62304. Our expert team included an MDR Project Lead and two additional consultants with experience in technical file documentation updates. They provided assistance with several tasks, including: 

  • Risk Assessment 
  • Classification 
  • Intended Use 
  • IFU Requirements 
  • MDR Requirements
The Result

The client has made considerable strides towards MDR compliance. The Oxford MDR Lead made a very positive first impression, and the client extended the contract multiple times. It was often remarked that the consultants were considered by management to be part of the QA/RA team. Due to this successful engagement, Oxford’s position as this client’s preferred partner to the quality and regulatory divisions was further solidified and strengthened.