Wiebe Postma Email & Phone Number

Arnhem, Ge, Nl

Waltham, Ma, Us

Clinical Evaluation, Post Market Clinical Follow-up, Summary of Safety and Clinical Performance, clinical studies documentation. Leading team of medical writers.

Riga, Riga, Lv

Advisory role for medical device-related product development

Arnhem, Gelderland, Nl

• Member of management team of the CRO branch of Qserve, responsible for regulatory intelligence, compliance and business development strategy.• Act as go-to person for clinical consulting services and CRO.• Regulatory and clinical strategy development for Class I, IIa, IIb, implantable and Class III devices.• Gap assessments on clinical evidence requirements and MDR compliance.• Practical implementation of ISO14155 Good Clinical Practice for medical device studies.• Development of standardized and custom trainings on ISO14155 GCP, Clinical Evaluation according MEDDEV 2.7/1 rev4, Medical Device Regulations, PMCF, Clinical Data requirements, and others.• Oversight of clinical operations, study start-up, submissions to ethics committees and applications to competent authorities, study management and data management.

Arnhem, Gelderland, Nl

• Advising medical device manufacturers on Medical Device Regulations, ISO14155 GCP, ISO14971 Risk Management, MEDDEV 2.7/1 rev 4 Clinical Evaluation.• Procedure development and template development for clinical evaluation, clinical investigation, post-market clinical follow-up (PMCF), monitoring and other clinical operations related procedures• Writing of Clinical Strategy, Clinical Development Plan (CDP); Clinical Evaluation Plan (CEP); Clinical Evaluation Report (CER); PMCF plan and report; Clinical Investigation Plan (CIP); Clinical Investigation Report (CIR); Monitoring Plan; Informed Consent Form (ICF); Investigators Brochure (IB); Risk Management Report; etc.

Arlington, Tn, Us

Responsible for international post market clinical trials (knee and hip prostheses) and clinical affairs in EMEA region. EU Authorized Representative for MicroPort Orthopedics Inc.

Basel, Baselstadt, Ch

Monitoring of Phase I - III oncology trials.

Groningen, Nl

Start-up and management of premarket clinical trials with intraocular lenses. Scientific member of R&D teams developing new lenses and insertion systems. Writing of clinical evaluation reports.

Wageningen, Gelderland, Nl

PhD Thesis: Modulation of innate immunity by plant-parasitic nematodes.

Boston, Ma, Us

Live demonstrations for museum visitors about various aspects of human and animal biology.

Boston, Ma, Us

MSc Thesis: The hormone Adiponectin in mother's milk protects newborns against infections.

Freiburg, De

MSc Thesis: Elucidation of molecular mechanisms by which human cells detect viral RNA.