Wiebe Postma Email and Phone Number
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Wiebe Postma personal email
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Clinical research professional | PhD in biology | 12+ years experience in Medical Device industry regulatory and clinical roles | Clinical evaluation including writing and evaluating Clinical Development Plans (CDP), Clinical Evaluation Plans (CEP), and Clinical Evaluation Reports (CER) | Clinical investigation including medical writing, Clinical Investigation Plan (CIP) development, study management, site management and monitoring | Post market surveillance (PMS) and post-market clinical follow-up (PMCF) | EU MDR, ISO 14155 GCP, MEDDEV 2.7/1, ISO 14971, ISO 13485 | Experience with a broad range of medical devices Class I-III and implants | Auditing | KOL engagement | Medical Affairs | Clinical Affairs | Regulatory Affairs | Compliance | Quality Assurance | Medical device R&D | Marketing and support of medical product claims and evidence-based medicine.Strengths: building bridges between clinical, quality and regulatory (cross-functional roles) customer oriented, accurate and ensuring regulatory compliance.
Bvi Medical
View- Website:
- bvimedical.com
- Employees:
- 961
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Bvi MedicalArnhem, Ge, Nl
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Sr Manager Global Clinical EvaluationBvi Medical Jun 2022 - PresentWaltham, Ma, UsClinical Evaluation, Post Market Clinical Follow-up, Summary of Safety and Clinical Performance, clinical studies documentation. Leading team of medical writers.
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Medical Writing And Regulatory AdvisorSummarizebot Jun 2022 - PresentRiga, Riga, LvAdvisory role for medical device-related product development -
Senior ConsultantQserve Group Jan 2019 - Jun 2022Arnhem, 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. -
ConsultantQserve Group Jan 2017 - Jan 2019Arnhem, 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.
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Manager, European Clinical AffairsMicroport Orthopedics Inc. Jun 2014 - Jan 2017Arlington, Tn, UsResponsible for international post market clinical trials (knee and hip prostheses) and clinical affairs in EMEA region. EU Authorized Representative for MicroPort Orthopedics Inc. -
Clinical Research AssociateNovartis Apr 2014 - Jun 2014Basel, Baselstadt, ChMonitoring of Phase I - III oncology trials. -
Clinical Research AssociateOphtec Bv Dec 2012 - Mar 2014Groningen, NlStart-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. -
Phd CandidateWageningen University & Research Jan 2008 - Nov 2012Wageningen, Gelderland, NlPhD Thesis: Modulation of innate immunity by plant-parasitic nematodes. -
Science EducatorBoston Museum Of Science 2007 - 2007Boston, Ma, UsLive demonstrations for museum visitors about various aspects of human and animal biology. -
Research InternMass General Hospital / Harvard Medical School, Pediatric Gastroenterology And Nutrition 2007 - 2007Boston, Ma, UsMSc Thesis: The hormone Adiponectin in mother's milk protects newborns against infections. -
Research InternUniversität Freiburg 2006 - 2006Freiburg, DeMSc Thesis: Elucidation of molecular mechanisms by which human cells detect viral RNA.
Wiebe Postma Skills
Wiebe Postma Education Details
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Wageningen University & ResearchGeneral
Frequently Asked Questions about Wiebe Postma
What company does Wiebe Postma work for?
Wiebe Postma works for Bvi Medical
What is Wiebe Postma's role at the current company?
Wiebe Postma's current role is Regulatory and clinical strategy towards MDR compliance, CE-marking and clinical data collection through premarket clinical trials and PMCF studies, registries, and surveys..
What is Wiebe Postma's email address?
Wiebe Postma's email address is po****@****ail.com
What schools did Wiebe Postma attend?
Wiebe Postma attended Wageningen University & Research.
What are some of Wiebe Postma's interests?
Wiebe Postma has interest in Cello, Social Services, Running.
What skills is Wiebe Postma known for?
Wiebe Postma has skills like Science, Scientific Writing, Clinical Trials, Clinical Research, Molecular Biology, Lifesciences, Immunology, Data Analysis, Medical Devices, Ich Gcp, Biotechnology, Research And Development.
Who are Wiebe Postma's colleagues?
Wiebe Postma's colleagues are Ahmed Barham, Giovanni Pernice, Donata Borzoni, Emiliano Rossi, Pascale Pirotton, Максим Ефремов, Goncalves Olivia.
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