Haveitmade Companies, focuses on highly complex and regulated products and processes establishment.
Worked with organisations such as Olympus, Genpact, McKinsey, Philips Health-Tech, ASML, Dekra, Canon, and various startups, gaining extensive international experience.
Resume Hans 2024 Q4.pdfCover Letter 2024 Q4 Johannes van Leuven.pdf201921 MED Hans van Leuven LAU-AU, UnA.pdfQualification 13485
Auditor (AU), Lead Auditor (LAU)
certificate-ISO 27001 Lead Auditor copy 2.pdfAuditor (AU), Lead Auditor (LAU)
27001 cyber security
DEKRA new QMS and Conformity assessment procedures according to ISO:IEC 17021-1-2015, MDR 2017:745, associated regulatory requirements and medical device knowledge updates in Arnhem, The Netherlands on September 19, 2019 smaller.pdfMDR training Notified Body
certificate- 45001.pdfAuditor (AU), Lead Auditor (LAU)
45001 Occupational Health and Safety
Certificate of Training - June 5-7, 2018 - Hans van Leuven.pdfConformity assessment procedures according to ISO17021-20112015, associated regulatory requirements and medical device knowledge updates in Wart, Germany on May 1-3, 2018 smaller.pdfCertificate Training MDR
md_actor_roles_srn_en_0 copy.pdfEU ACTOR Roles
201917 MED Hans van Leuven LAU-AU copy TUV.pdfCertificate Lead Auditor
Statement Degree Certificate Higher Education.pdfStatement of Degree
Common Gaps MDR presentation related to Software for MDR including special attention for medicinal products.
Video sheets run fast to save data USE PAUSE BUTTON to Still the sheets
Haveitmade Companies is Participating and promoting a Medical Device Open Source Project Presentation holds extended pitch
Goal: Increasing Diagnostic Health technology Availability, trustable, affordable, adaptable Better global Health Acces SDG 3
Problem: Worldwide shortage of health workers threatens effective health coverage.
Solution; Use of Artificial intelligence / Machine Learning to Support for Scanning using an Open-Source Scanner, sharing raw health data
Subscription Payments of support, indexed on:
Type of service: support to decision making and/or cloud storage;
Complexity of the analysis - COVID-19 for example could be cheaper than kidney stones detection or deep vein thrombosis diagnostic
Human support e.g. to involve a telemedicine expert to check the ML / Machine Learning analysis
Country of operation : fees could be lower for developing countries, backed with support from donors programs like WHO or UNICEF to subsidize the cost and equipment
Contributor status: as an incentive, all users who contribute to the knowledge database by sharing their images would get a discount on their subscription as compensation.
Below Some Youtube Videos Related to Completed Projects Johannes (Hans) van Leuven was involved in as Consultant via Haveitmade Companies
