IMed Consultancy supports Summit Medical with renewing their CE Marking –
Summit Medical Group Ltd is a UK based global leader in the provision of orthopaedic surgical products and an innovative market leader in cementation, with a commitment to innovation, service and quality. Trusted by clinicians, physicians, hospitals and patients alike, the Summit Medical Group brand embraces both Group divisions Summit Medical and Marlux Medical and in doing so, projects a uniform business identity across all of the 40 plus international markets where the brand distributes.
Summit Medical first reached out to IMed Consultancy in December 2022 for assistance to update a Clinical Evaluation Report (CER) in support of their MDR transition journey.
“Clinical evaluation and the relevant supporting documents represent a significant aspect of demonstrating compliance and require a specific set of skills and knowledge. With no time to waste and the holidays coming up, we decided to rely on IMed Consultancy’s proven expertise to make sure our MDR submission was up to standard” explains James Halliday, Head of QA/RA at Summit Medical.
IMed Consultancy supported Summit Medical with all their clinical evaluation activities: from the completion of literature searches to the drafting of a new and much improved CER. The unparallel responsiveness, short turn-around time and outstanding quality of the work delivered by IMed really made a difference, allowing Summit Medical to submit all documents on time.
“We were really impressed with IMed. Considering the short notice – and Christmas – they went above and beyond to deliver within the timeframe they promised us. They did such an amazing job with our CERs: all was up to standard, the quality was outstanding and we received positive feedback from our Notified Body,” continues James.
“We’re thrilled to have been able to support Summit Medical in updating their clinical evaluation, which is a critical step towards EU MDR compliance. We pride ourselves in sharing our clients’ goals and achievement, working with them rather than for them and our work with Summit Medical is a prime example of that!” declares Leeanne Baker, founder at IMed Consultancy.