E
ElmerF
Hello, I'm new to the forum. Just wanted to say how much I appreciate the exchange of information and thank all the contributers.
With regard to the update to 10993-1 2009, conducting a material risk assessment is now compulsory. My background in QA/RA and the standard calls for "The biological evaluation shall be planned, carried out, and documented by knowledgeable and experienced professionals.....The risk management plan should identify aspects of the biological evaluation requiring specific technical competencies and shall identify the person(s) responsible for the biological safety evaluation. " Just wondering what companies are doing here. Is it acceptable for companies to conduct these assessments themselves or hire material and toxicology experts or perhaps just include expert opinions on higher risk materials, implant.
Also anyone know where I might find a general template to get an idea of what is required?
Thanks for your suggestions.
With regard to the update to 10993-1 2009, conducting a material risk assessment is now compulsory. My background in QA/RA and the standard calls for "The biological evaluation shall be planned, carried out, and documented by knowledgeable and experienced professionals.....The risk management plan should identify aspects of the biological evaluation requiring specific technical competencies and shall identify the person(s) responsible for the biological safety evaluation. " Just wondering what companies are doing here. Is it acceptable for companies to conduct these assessments themselves or hire material and toxicology experts or perhaps just include expert opinions on higher risk materials, implant.
Also anyone know where I might find a general template to get an idea of what is required?
Thanks for your suggestions.