aepEX PLUS
The aepEX PLUS system dynamically measures the balance between hypnosis, analgesia and surgical stimulation using Auditory Evoked Potentials (AEPs), providing the anaesthesia community with a fast, accurate and compact depth of anaesthesia monitoring system utilising proven technology.
MDM developed the aepEX monitor based on a concept. Work included design of a custom injection moulded case, working with 3rd parties to develop the PCBs and software.
We also compiled technical file and obtained regulatory approval for the aepEX product.
We then manufactured and tested the product at our site.
Ceramisys
Ceramisys is a leading international biomaterials manufacturer with a strong focus on orthopaedic and spinal applications. MDM has worked with Ceramisys for 20 years initially assisting them to implement a Quality Management System (QMS). We have continued to work with Ceramisys to develop the QMS to meet their evolving business needs and meet the evolving regulatory requirements.
When the United Kingdom left the European Union Ceramisys needed to appoint an EU authorized representative (EC Rep) in order to continue selling their products in EU countries. MDM were able to become Ceramisys’ EC Rep through our Irish subsidiary.
MediSieve
The MediSieve filter is an innovative single use magnetic blood filter designed to capture magnetic components in the patient’s blood. The filter is used with biocompatible magnetic particles coated with binding agents so that they attach to specific targets such as cells, toxins, antibodies, and inflammatory cytokines.
MDM worked with MediSieve to develop and manufacture the filter. MDM’s work included:
- Mechanical design of custom moulded parts for the filter
- Design of labelling for the filter packaging
- Identification of materials & parts from suppliers
- Facilitate testing of the product including: biocompatibility, bioburden, endotoxin, sterility, endotoxin
- Develop and implement the cleanroom manufacturing process at MDM’s manufacturing facility
- Setup a sterilisation process with a local company