Experienced CEO, Non-Executive Director and Consultant, with a strong technical background and broad experience in driving business transformations in different markets & fields, often under challenging conditions. Strategic thinker; capable of quickly understanding complex business, organizational and technical problems and working with the executive team to identify the best way forward. As part of MD squared, we help MedTech companies to navigate the complex regulatory jungle. Successfully bringing innovations to the market requires careful consideration of many different aspects. The exact product description, intended use and claims directly impact the regulatory pathways and the required clinical evidence. The level of outsourcing and select partners, directly impact the scope of the QMS implementation and the documentation burden required. All these choices directly impact the business case, development timelines and funding needs. With a multidisciplinary team, we work with companies to identify the best approach to bring new meaningful innovations to patients in a timely fashion. We provide insights and work out scenarios to allow our clients to make informed choices. We build long-term partnerships and work together with clients to help them cut a pragmatic path through the jungle. From guiding risk management sessions to drafting regulatory plans and from drafting Clinical Evaluation Plans and reports to staged and risk-based Quality Management System implementations. We work with our clients to get their innovations to market faster!
Listed skills include Optics, R&D, Product Development, Innovation Management, and 27 others.
