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Evelyne Buehler

Over twelve years of experience at a leading medical device manufacturer

Analytical and reliable working style

Professional Background

While working in the clinical department of Institut Straumann AG, 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 during my first years, I have a deep understanding of data coming from studies.

Post-Market Clinical Follow-up positions at Institut Straumann AG
- over 8 years

12/2023 – 07/2026

Senior PMCF Manager

  • Contributed to the strategic and operational management of PMCF activities across the product portfolio

  • Established and maintained PMCF plans and reports

  • Provided input to Clinical Evaluation and Post-Market Surveillance documentation

  • Synthesized and reported clinical data from scientific literature, registries, surveys, clinical investigations and scientific conferences

  • Planed, coordinated and oversaw PMCF deliverables and timelines

  • Continuously improved PMCF processes and methodologies in collaboration with internal and external stakeholders

  • Supported Notified Body audits and technical file reviews

08/2022 – 11/2023

PMCF Team Leader

  • Led the newly created PMCF team

  • Oversaw, prioritized and allocated PMCF assignments

  • Supervised the PMCF strategy over the entire Straumann product portfolio and led the PMCF process

  • Provided functional leadership and supervision to a PMCF Manager

  • Acted as the primary contact for PMCF-related requests from Notified Bodies during audits and technical file reviews

06/2018 – 07/2022

Clinical Program Manager

  • Established and continuously developed the PMCF process to ensure compliance with the medical device regulation (MDR) in alignment with Clinical Evaluation, Risk Management and Post-Market Surveillance
  • Developed and advanced the PMCF strategy for the Straumann product portfolio including identifying innovative approaches to generate post-market clinical evidence 
  • Oversaw the planning and execution of PMCF tasks in collaborations with internal stakeholders
  • Coordinated the execution of PMCF tasks with cross-functional stakeholders
  • Established and maintained PMCF plans and reports
  • Identified and implemented appropriate PMCF activities to generate required clinical evidence
  • Followed-up on PMCF activities and participated in the cross-functional evaluation of identified signals
  • Contributed to Clinical Evaluation, Post-Market Surveillance and Clinical Research documentation
  • Acted as the primary contact for PMCF-related requests from Notified Bodies during audits and technical file reviews

Clinical Study Management positions at Institut Straumann AG
- over 4 years

04/2014 - 05/2018

Clinical Trial Leader
Clinical Research Associate

  • Managed sponsor-initiated post-market clinical investigations for medical devices in accordance with ISO 14155

  • Managed investigator-initiated studies globally

  • Established and maintained relationships with investigators and study teams

  • Coordinated and managed external service providers including CROs, statisticians and medical writers

  • Collaborated with and aligned internal stakeholders including Regulatory Affairs, Product Management and Legal

University Education - ETH Zürich

Master of Science in Human Movement Sciences

Specialisation in Biomechanics

Biomechanics, Mechanics, Mechanobiology, Orthopaedic Biomechanics, Biomedical Engineering, Bionics and Medical Implants, Rehabilitation Engineering

Bachelor of Science in Human Movement Sciences

Biology, Chemistry, Biochemistry, Neuroscience, Mathematics, Physics, Statistics, Informatics

Functional Anatomy, Anatomy & Physiology, Biomechanics, Motor Control and Learning

Trainings and Courses

Medical Device Regulation, Post-Market Clinical Follow-up, Clinical Evaluation and Post-Market Surveillance:
  • PMCF: Various online webinars throughout 2013-2026 including real-world evidence, survey conduction, off-label use and AI& software as a medical device. Lead by Qserve, Purdie Pascoe and others involving TÜV SÜD and BSI
  • Clinical Evaluation for Medical Devices (6 hours, 2025) – Life Sciences Academy
  • 4th Annual European Medical Device and Diagnostic Post-Market Proactive Surveillance & Vigilance Conference (2 days, 2022) – TT group
  • Clinical Workshop on Requirements of Register (two-day training, 2019) – TÜV SÜD
  • MDR Workshop (12 hours training, 2018) – TÜV SÜD
  • Overview of the new Medical Devices Regulation and Clinical Evaluation (one day, 2018) – SFL (Solutions For Life sciences)
  • Clinical evaluation according to MEDDEV 2.7/1 rev. 4 including literature search methodology (one day, 2018) – SFL (Solutions For Life sciences)
  • Clinical Aspects of the Medical Device Regulation (12 hours training, 2018) – TÜV SÜD
Clinical Research:

  • ISO 14155: Regular trainings/ refreshers. Last refresher 01/2026: ISO 14155 Refresher & ICH GCP E6 (R3) Highlights (3 hours, online) – ECCRT (European Centre for Clinical Research Training)

  • 12th Annual EU Medical Device Clinical Research Conference (three days, virtual, 2020) – Q1 Productions

  • 4th European Medical Device Investigator Initiated Study Meeting (two days, BEL, 2020) – TT group

  • 1th Annual EU Medical Device Clinical Research Conference (2 days, DE, 2019) – Q1 Productions

  • 2nd Annual European Medical Device Investigator Initiated Study Meeting (two-days, BEL, 2018) – TT group

  • Medical Device Clinical Project Management Certificate including Risk Management Basics Certificate (1476 min, online, 2018) – WMDO (World Medical Device Organization)

  • 5th Annual Outsourcing in Clinical Trials: Medical Devices Europe (two-day conference, DE, 2018) – Arena International

  • “Praxiswissen IITs” (one-day course, DE, 2016) – Forum Seminar

  • “Medizinprodukte: Multinationale klinische Prüfungen“ (two-day course, DE, 2015) – Forum Seminar

  • “Monitoring von klinischen Prüfungen bei Medizinprodukten“ (two-day course, DE, 2014) – Forum Seminar

  • “Klinische Prüfung von Medizinprodukten“ (two-day course, DE, 2014) – Forum Seminar

  • “4th Annual EU Investigator Initiated Studies” (two-day conference, DE, 2014) – Q1 Conference

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