Schlagwörter
Skills
Projekthistorie
„Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling“; ISO
17664:2017; Recommendation from the Commission on Hospital Hygiene and Infection Protection at the
Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM) on the "Hygiene
requirements for the reprocessing of medical devices"), MDR readiness, authoring of scientific / literaturebased
Peer Reviews, Reporting; Biocompatibility Assessment for Implants. Biocompatibility Evaluations
(extractables/leachables), according to ISO 10933 for a series for polymer implants, together with a
toxicologist, including interpretation of MS spectra measured by a contract lab (evaluation reports); answering
deficiency letters of notified body.
manufacturer); support URS, selection process and customizing of new CAPA software and procedure;
supporting preparation of 510(k) documents and technical documentation, Intended Use (Product Claim) acc.
to IVDR / MDR Article 7 for various products; application of IVDR/MDR rules for correct registration according
to Product Claim and advice regarding content of IFU, labelling; conducting online-trainings on QM topics and
internal audits according to ISO 13485:2016; project lead and final project evaluation (questionnaire)
tailored Quality Manual, SOPs, Supplier / Contract manufacturer Audits, Regulatory Audits, GDP, responsible
external QM Manager, communication with local authorities.
Audits, due to Corona pandemic remote audits:
- 06/2020: contract manufacturer qualification as document & online audit (manufacturer, regulatory, QM
- and general services)
- 09/2020: contract manufacturer qualification as document audit & video audit (manufacturer in France,
- GMP/GDP)
- 11/2020: contract manufacturer qualification as document & video audit (archiving service)
- 04/2021: contract manufacturer qualification as document & video audit (logistics, GDP)
- 06/2021: selection process and qualification by questionnaire of pharmacovigilance contract service
- provider
- 06/2021: contract manufacturer qualification as online/video audit (manufacturer, GMP)
Reisebereitschaft
exali consult-Haftpflicht-Siegel
Das original exali consult-Haftpflicht-Siegel bestätigt dem Auftraggeber, dass die betreffende Person oder Firma eine aktuell gültige branchenspezifische Berufs- bzw. Betriebshaftpflichtversicherung abgeschlossen hat.
Versicherungsbeginn:
15.04.2018
Versicherungsende:
01.05.2026