I am bioengineer and work as a regulation affairs specialist. I am looking for a freelance consultancy. Also I can entry basic datas like secretarial issues. I am working on CE certification of medical devices class I,IIa,IIb and III. I prepare design dosier, that contains validations, product identification, design parameters, biocompatibility and biomechanical tests evaluation and the needs that MDD or MDR. Clinical evaluation report is new important area for medical device dosier. The manufacturers should evaluate all data from market and new articles. I will arrange PMCF(post marketing clinical follow-up) ans PMS(post marketing surveillance) reports. I can evaluate all datas. Sometimes biocompatibility or other tests needed of regulation, I can justify it with reports. Also I organize the documents of ISO 13485. I will arrange procedures, quality plans etc. In another perspective I will entry data like secretarial issues.