Summit Medical has announced the successful attainment of the European Medical Device Regulation (MDR) certification. Securing the EU MDR 2017/745 certificate, granted by the Notified Body SGS Belgium NV, signifies the company’s ongoing commitment to maintaining pinnacle standards in quality and patient safety.
Summit Medical is one of a few companies to receive MDR certification and meet the strict European regulatory standards in the development, manufacturing and distribution of medical products.
Chris Lee, CEO at Summit Medical, commented: “The announcement confirming Summit Medical’s achievement of EU MDR certification was a critical milestone for the business and paves the way for our continued growth both through our existing portfolio and the pipeline of new technologies we have been developing.
"The collective team effort has been incredible, and the award is a ringing endorsement of our commitment to the processes that underpin the quality that Summit places at the heart of everything we do.”
Ensuring compliance with the latest regulatory standards involved meticulous organisational processes such as a robust Quality Management System (QMS), risk management procedures as well as clinical validation and usability of the medical devices, requiring coordinated efforts across multiple functions.
James Halliday, Head of RA / QA at Summit Medical, who guided the MDR certification process, shared his insight into navigating the challenges and a successful outcome: “Receiving EU MDR certification marks a major landmark in the regulatory history of Summit Medical. Certification represents many months of collaborative effort across the business and is a tangible endorsement of the quality of our processes as well as the safety and performance of our products.
"Perhaps most importantly, MDR certification facilitates Summit’s ability to grow the EU product portfolio through the introduction of new and innovative solutions in the Orthopaedic sector.”
The MDR certification opens new avenues for Summit Medical to drive ongoing innovation within its product family, allowing the introduction of advanced, compliant medical solutions to the European market.
