John Magnuson

Background

About John Magnuson

I got in biocompatibility testing because the company I work at thought that my molecular biology background from college was close enough because they both had "bio" in the name. What I ended up finding was an interesting suit of testing that my background did help me understand. I started my career in a department of two, so I became familiar with a wide range of biocompatibility testing along with sterile barrier testing and gamma radiation sterilization. I'm looking to make more connections with people in biocompatibility and new opportunities in the field. I'm currently working on-Planning and organizing Biocompatibility testing suits per ISO 10993. This includes coordinating with facilities for biocompatibility testing of the device-Writing test procedures and updating SOPs pertaining to biocompatibility, sterile barrier and sterilization validation-Assisting the toxicologist with toxicological risk assessments after extractables and leachable testing-Supporting regulatory affairs by writing or aiding in writing of testing summaries submitted to the FDA-Supporting regulatory affairs by writing or aiding in writing responses to the FDA questions. Resulting in 9 successful 510K submissions K191313, K202690, K213536, K232316, K233952, K241178, K233557, K240290 and K241736.