Ironcountry
Industrial
The company that I work for has a team that is in the process rewriting and/or creating specifications for various plastics used as components for medical instruments. Initially, requirements were taken from both resin and extruded material which proved to be problematic in being able to consistently have the information included on the material cert. The mistake we made was to apply the same approach to plastics that we had for metals. What I'd like to request is how other medical device manufacturer's approach plastics and what information is really required on a material certification.