Mique Saes, Phd Email & Phone Number

Utrecht, Nederland

Responsible for amongst others auditing of Dutch Notified Bodies against MDD, MDR, IVDD, and IVDR.Obtained certificate:- Lead auditor ISO 13485

Bilthoven, Utrecht, Nederland

secretaris ondernemingsraad

Helping manufacturers to become compliant with the regulations in order to get or keep their product on the market. We guide them through this process by performing gap analyses and propose how they can improve. We perform clinical evaluations to conclude whether a medical device complies with the applicable General Safety and Performance Regulations, help them writing technical files, and share our knowledge as consultants. In addition, we write protocol and reports for clinical investigations.Relevant regulations/standards:MDD, MDR, ISO14155, ISO13485Technical files:CER, PSUR, PMS, PMCF, SSCP, CSR/CIR, IB, IFU, CDP, HSHA, Hazard analysis, Risk analysis, risk-benefit.Skills:Project management, coaching, training, client contact, communication, critical thinking, reporting, data analysis, statistics.As member of the task forces for 'standards and regulations' and 'software as a medical device' I stay up to date and inform colleagues about ongoing changes such as new MDCG guidelines.

Amsterdam En Omgeving, Nederland

clinical investigation, quantitative data analysis (programming, statistical analyses), scientific writing and presenting outcomes to a diverse audience. Focused on longitudinal data analyses and prediction modelling.Part of the NeuroControl consortium. see www.neurocontrol.nl Projects: 4D-EEG: Development of cortical activity and clinical measures during recovery post stroke. NeuroCIMT Ambition: Ambulant sensing of motion after stroke.

Amsterdam

Projects in which I participated are: 4D-EEG and Profits. In both multi-center studies dynamics of recovery was investigated in acute stroke patients during their recovery period. Main tasks: research coordination, METC contact, amendments, data management, planning, performing measurements.

Amsterdam

VU University Research Fellowship (URF) is a programme developed for a select number of internationally renowned scientists at VU University Amsterdam. Fellow of Professor Dr. G. Kwakkel.

Amsterdam

This internship at the Department of Rehabilitation Medicine was part of the 4D-EEG project about upperlimb recovery of stroke patients. During this internship I've gained experience in clinical research (especially with stroke patients), conducted clinical trials and performed EEG measurements, analyses and wrote a scientific report.

Teaching and supervising a group of bachelor students during the Biomechanics course at the faculty of Human Movement Sciences.

Master Of Science (Msc), Research Master Human Movement Sciences, Cum Laude

Specialization: Rehabilitation Research Internship at the Department of Rehabilitation medicine at the VU medical centre. 4D-EEG project |.

Honours Program

During the Honours programme I have expended my knowledge about different disciplines such as philosophy, statistics and neuroscience.

Bachelor Of Science (Bsc), Human Movement Sciences, Cum Laude And Honours Programme

Minor: BWSB (Bouw, Werking en Sturing van het Bewegingssysteem / construction, operation and coordination of the locomotor system)