Guides and supports the business in EU MDR transition and implementation of other EU regulations. Works collaboratively with regulators, trade associations, customers, and other stakeholders regarding standards, guidances, whitepapers etc. Represent Philips on software standards committees (e.g. JWG7)

This group develops EU guidance that supports a pragmatic implementation of the MDR with respect to medical device software. It monitor developments on apps and standards for software at EU and international level.

IAF's goals are to - have an open exchange on current standardization issues;- identify and advise on standardization priority topics for the European industry;- express suggestions, expectations, and concerns to identify common solutions;in view of providing advice to the CEN and CENELEC corporate governing and advisory bodies, and proposing medium- and long-term industry-driven standardization objectives for CEN and CENELEC to undertake in order to reach the Strategy 2030 Goals and beyond.

Training and consultancy on navigating and practically implementing laws, regulations and standards that affect medical device software and health apps.

As member of the industrial liaison network I evaluate the business and market potential of innovative research projects and determine their feasibility for the development of a license-model or the creation of a university spin-off.

The purpose of this standard is to develop a set of principles for health and wellness app developers to follow throughout an app project life cycle, so that health care professionals, patients and the public trust their products and services. The project proposal for this subject was approved by CEN/TC 251 in 2017 and has been endorsed by the European Commission for support (specific agreement 2018-03) for the development of a European Technical Specification.

In my position of Quality & Regulatory Affairs Manager I make instant, plug-in-and-play contributions to small, highly flexible teams with fluctuating daily needs. On a day to day basis I moderate discussions between doctors, development teams and regulatory authorities to determine the best approach for establishing the clinical evidence for software-only products in the field of oncology, cardiology and orthopaedics. I write the 510(k)'s myself. These are sometimes high risk, borderline PMA. My end-goal is a successful regulatory filing (usually worldwide), a happy team with satisfied patients and customers. By education I'm a master in risk management. In my position of Manager of Agfa's Risk Management Process I developed and now maintain Agfa's closed-loop risk management process. It serves 200 users worldwide both pre- and post-market. In 2012 I made the process more objective and data-driven by embedding a causal-chain probability break-down. I also manage Agfa's Regulatory Monitoring process, a process aimed at adapting Agfa's quality management system to a changing regulatory environment.I also manage Agfa's Market Surveillance process which I designed and am now adapting together with the risk management and vigilance process to meet the requirements of the European MEDDEV 2.12-1 on trend reporting.My main expertise lies with software: clinical applications for general radiology, oncology, neurology, cardiology and orthopedics, computer algorithms for pattern recognition, computer aided detection, reasoning engines, decision support, clinical pathways, general systems such as HIS, LIS, IVD, PACS, EPR and mobile apps. I have some experience with medical printers and film. Working knowledge of FDA, MDD and IVDD regulations. In-depth knowledge of EU and US privacy regulations and the following standards: IEC 62304, ISO 14971, ISO 13485, ISO 9001 and IEC 80001.

PGP develops LIS-middleware used by IVD labs, blood banks and also by pharmaceutical companies for product development and clinical trials. I developed PGP's risk management and validation process. We validated (1) in-house against generic user requirements and (2) on-site against home-brewed diagnostic methods, clinical pathways and connection to new analyzers, allowing our customers to validate their production plants against GLP standards. Once the processes were set up I implemented elements of a 13485:2003 quality system.

I started as Service and Application Specialist for Lunar. Lunar is a spin-off of NASA space research and a world leader in dual-energy x-ray absorptiometry (DEXA) and ultrasound scanners for the diagnosis and monitoring of osteoporosis. DEXA scanners are also used for the follow-up of body composition changes. In 2000 Lunar was acquired by GE Healthcare. As a Training Officer I organized trainings for engineers, sales force, application specialists, doctors and nurses in a region as large as Europe, the Middle East, Africa and some countries in Western Asia. I worked in collaboration with opinion leaders & researchers to develop new applications and provided technical know-how for the creation of solutions for pharmaceutical companies. I participated in the organization of user meetings and PR-projects. In 2002 I received additional regulatory & safety responsibilities.

Development and production of stainless steel products/processing plants for the food and pharmaceutical industry.