Medical Device Development Consultant
For MedTech start-ups and Scale-ups
Over 10 years of MedTech entrepreneurship experience to support your organization.
With a desire to share my skills, know-how and experience in MedTech entrepreneurship, I support start-ups and scale-ups with their challenges in medical product development, production, quality management and certification.
Thijs van Oorschot, MedTech Companion
What I do
Product Design & Development
Ensure a methodological development process to translate user requirements into sensible product requirements and specifications to create innovative and user-friendly solutions for your clients. Assure product safety through risk management, design verification and product validation and closely cooperate with development and production partners to deliver high-quality products.
Quality Assurance
Support with setting up a (electronic) Quality Management System; establishing procedures, work instructions and forms for quality assurance within the organisation with an emphasis on the implementation of design controls and associated design records (Design History File).
Regulatory Affairs
Defining the regulatory pathway and mapping out applicable regulations and (technical) standards (i.e. Quality Management, Risk Management, Electrical Safety, Biocompatibility and Software Lifecycle Management). Supporting various activities to ensure regulatory compliance and preparation of regulatory submission.
Intellectual Property
Assessing options for intellectual property protection, supporting communication with patent attorneys and provide guidance on patent (infringement) analysis and/or Freedom to Operate trajectories.
Core Values
Methodical
Organising processes, structuring decision making & outlining steps to be taken.
Pragmatic
Take realistic decions, execute sensible actions and create practical solutions.
Trustworthy
Being transparent,
honest and sincere.
Cooperative
A team-player with a social and supportive character.
