Nilaykumar Patel

Head of Quality / PRRC / DPO / CISO

contextflow GmbH

Vienna, Austria

3 profile visitsSpeakerSpeaker

Life Science Professional with 15+ years of international combined experience in AI/ML-SaMD regulation & Audits, Strategic Planning & Startup Mentorship

My organisation

contextflow GmbH

Small and medium-sized enterprise

Vienna, Austria

contextflow ADVANCE Chest CT provides radiologists comprehensive computer-aided detection support for suspected lung cancer, ILD and COPD cases. Its main features are designed to help save time and improve reporting quality: nodule detection and quantification, nodule tracking over time, quantitative lung tissue analysis for key image findings, and qualitative analysis of 19 image patterns plus reference cases and differential diagnosis information.

About me

WORK EXPERIENCE

01/2023- present

Honorary Member | Technical Committee ISO / IEC | Vienna | Austria
07/2021-present

Senior Consultant in Quality & Regulatory & Auditor | en.co.tec Schmid KG | Vienna | Austria
02/2019-present

Head of Quality / PRRC / DPO / CISO | contextflow GmbH | Vienna | Austria
02/2018-12/2019

Volunteer Organiser | Young Life Scientists Austria - ÖGMBT | Vienna | Austria
07/2016-03/2018

Technical Assistant | Department of Pharmacognosy | University of Vienna | Austria
02/2015-12/2015

Research Assistant | BioSensor Technologies | AIT GmbH | Vienna | Austria
07/2014-12/2014

Lab Assistant | Ludwig Boltzmann Institute | Vienna | Austria
08/2012-07/2013

German HelpDesk Adviser | Solid Systems Global | Ahmedabad (India) & Derby (UK)
11/2011-07/2012

Business Development Manager | Schneider Electric Distributor, S.Kumar Computers P.L. | Ahmedabad | India
02/2011-10/2011

02/2010-01/2011

01/2004-08/2008

EDUCATION

2022-2024 FH Technikum Wien (Austria) | MBA Healthtech Management

Focus: Strategic business planning, Market access of MDs & IVDs, Intrapreneurship & Entrepreneurship, Team management & Leadership
2015-2018 FH Campus Wien (Austria) | MSc Molecular Biotechnology

Achievement: MSc conferred with high distinction, performance scholarship
2008-2009 & 2013-2015

FH Technikum Wien (Austria) | BSc Biomedical Engineering

SKILLS AND KNOWLEDGE

● MDSAP - Requirements & Preparation | TüV SüD | 2024

● MDSAP training | en.co.tec | 2022

● Certified Internal Quality Auditor TÜV® | TüV Austria | 2021

● REGULATORY EXPERT Medical Devices & IVDs | en.co.tec | 2021

● EU AI Act - Technical Documentation for High-Risk AI Systems | Validate ML | 2021

● Internal Auditor ISO 13485:2016 & Regulation (EU) 2017/745 | en.co.tec | 2020

● EU MDR 2017/745 & ISO 13485:2016 gap analysis | en.co.tec | 2020

● ISO 13485:2016 - Quality Management for Medical Devices | en.co.tec | 2019

● Regulation (EU) 2017/745 & 2017/746 | AGES | 2019

● GLP | Regulatory affairs - Quality Management) in pharma industry | AGES | 2018

● Quality in Pharma: ICH/GMP guidelines | AGES | 2018

● Regulatory framework conditions for the validation of analytical methods, control of the finished product, impurities and stability | AGES | 2018

● Strategic leadership & entrepreneurship, product management | FH Campus Wien 2016

● Project-, Process- and Quality Management | FH Technikum Wien 2015

PUBLICATION

Publication Joint First Author Publication in Nature Publishing Group: “A comparative study of

Social media

Skills

MBA
Biomedical Engineering
MDSAP
AI/ML
Compliance
Regulation
FDA
MDR
MLMD
ISO
audit
Auditor
ISO 13485
IEC 62304
Cybersecurity

Interests

Compliance
audit
AI/ML
MLMD
MDR
FDA

Speaker sessions (1)

Wednesday, 15 October 2025

15:15 - 16:30

C1: Cybersecurity and IT security

Room 1: Maria Theresia

Tina Vodopivec: Cybersecurity of Software in Healthcare and Medical Devices - the Role of the IEC 81001-5-1 Standard
Nilaykumar Patel: Cybersecurity for SaMD: Cybersecurity-related Documentation in Technical File Preparation for Review by Notified Body
Larissa Naber: The Connected Medical Device and Its Natural Enemies