Testimonials

"Leeanne has solid experience in quality systems for development and manufacture of sterile medical consumables, and was able to tailor the SOPs and documentation systems to fit our product characteristics and scale." 

"Without the help and expertise of Leeanne and her team it would have taken us significantly longer to reach our goal, we would recommend IMed Consultancy to anyone needing help in navigating the challenges and pitfalls involved in meeting the current requirements for technical files in medical devices."

"The IMed team have helped us, and our global suppliers, to navigate the new regulatory burden and transition from MDD to MDR. They have managed the process throughout presenting workable solutions, enabling us to focus on our key business objectives. I look forward to working with them for our ISO13485 certification and wouldn’t hesitate to recommend the IMed team to deal with any Quality and /or Regulatory need."

"SureScreen Diagnostics worked closely with IMed in the process of gaining an Exceptional Use Authorisation from the MHRA for the SureScreen SARS-CoV-2 Rapid Antigen Test Cassette.  This involved pulling together and evaluating numerous data sets from Usability and Clinical Evaluation Studies, alongside optimising the technical file and Instructions For Use for the self-test device.

‘IMed have a great team who are very knowledgeable about the regulations for IVDs, and we were able to work with them like they were an extension of our own team which worked really well in practice.   They were invaluable in helping us move so quickly to address the market need.The team at IMED were always very helpful, easy to contact, and they went above and beyond to ensure that the process was as smooth as possible and deadlines were met.’