Mike 'O''Neill''s Contact Details

Mike 'O''Neill''s Company Details

Dorchester BioMedical was formed to research, develop and deliver medical and biomedical products that meet the patient's needs in the modality for the surgeon. Our focus is not just on the solution for the patient, we also learn and incorporate the user modes in our products. Our group is based in Boston, MA home to some of the leading research and teaching hospitals in the world. While we develop and deliver our own designs we don't have a "Not Invented Here" attitude. We have and will continue to work with other companies and researchers to realize their products. Our group has delivered products which comply with all regulations to legally sell and distribute in USA, Canada, EU, Japan, Hong Kong and many other countries around the world. Our capabilities are not limited to technical aspects only. We have written and delivered quality manuals as well as audit preparation for 13485 for start-up companies. We have successfully worked with the FDA to ensure proper product classification as well as appropriate development of clinical trials and required data.