Services for Post-Market Clinical Follow-up (PMCF) and related areas
Flexible and reliable support for medical devices manufacturers to meet the requirements of the EU MDR
Post-Market Clinical Follow-up (PMCF)
Continuous clinical evidence generation after market placement — planned, executed and documented so that it stands up to notified body scrutiny.
Interactions with related areas
Optimize interactions with related functions such as Clinical Research, Clinical Evaluation, Post-Market Surveillance and Risk Management — for a smooth process, the right data and to avoid unnessary questions from the Notified Bodies.
About me | Evelyne Buehler
I possess over twelve years of experience within the clinical department of a leading medical device manufacturer (Institut Straumann AG). Developing strategies and finding solutions is my passion. I set up the post-market clinical follow-up unit, including establishing procedures and templates and defining the PMCF strategy across the product portfolio (Class I to Class III devices). Maintaining PMCF documentation was a core responsibility and I was actively involved in collecting and reporting varoius types of PMCF data (studies, surveys, registries, user feedback, literature searches and screening activities). Having managed clinical trials before I have a deep understanding of data coming from studies.