Founding Purpose:
Dorchester BioMedical was formed to research, develop and deliver medical, biomedical and healthcare products that meet a patient’s need. Point of Need (PoN), Point of Care (PoC) or Point of Service (PoS) our focus is the patient. We are 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 internal audits 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.
Operating model:
We are committed to operating an efficient company to control our costs and development cycles. We work to achieve this by leveraging existing technology, partners and consultants that have direct experience with the projects we engage in.
Experience:
We have direct experience with a number of medical, biomedical and healthcare devices, including, but not limited to, wireless gamma probes, controlled hypothermia induction, robotic surgical probes, tissue sealant, ultrasound detection for breast cancer, RFID tagging for breast tumors and home health monitoring.
Quality:
We have a QMS which is supported by our quality manual; over 40 Standard Operating Procedures and associated forms.