A biologically safe medical device is a “must” for a clinically successful product. Biological safety is an important subject for the patient, the manufacturer and regulators. Regulators have put a clear requirement to evaluate the biological safety of a medical device before it is brought into contact with the patient. They provided guidance by means of the EN ISO 10993 series of standards and FDA – Blue Book Memorandum #G95-1 listing what aspects shall be taken into consideration. For the manufacturer biological safety evaluation is often a more complex subject because it also means a balance between a new medical device design with a specific use, application and functionality, selection of raw materials, control of the production process, control of development and production costs, development timelines and time to market.

MDProject can help you to keep this balance because we have a unique expertise in biological safety evaluation which has been build up over more than 25 years by:

– Being Project Manager or Biological Safety Expert Member in Design & Development teams
– Having practical experience with safety studies as COO and Study Director of a test laboratory for biological safety testing
– Being Expert contractor for Notified bodies for reviewing Technical Dossier on biological safety evaluation
– Being member in EN ISO standardization committees for biological safety evaluation
– Holding a PhD in biological safety evaluation of degradable polymers for medical devices

Learn more on how to benefit from our experience

MDProject can assist you with:

– The set up and writing of a biological safety evaluation strategy
– The decision if parts of the biological safety evaluation can be covered by a scientific literature review
– Scientific writing of the literature study
– Selection of a test laboratory
– Communication with this lab for defining appropriate test program, combination of tests, technical contents of the test, set up of functionality studies, monitoring test timelines
– Interpretation of tests results; especially in cases were results are not so straight forward we help you with solving these deviations
– Writing of an overall biological safety test report
– Interpretation if a design or process change affects the biological safety of a medical device

In case (more) knowledge and expertise is needed in your current Design and Development Team see also our training and coaching program.