Who is Efficacy?

Efficacy was founded in 2014 by Ole Overgaard. Efficacy is run and owned by Ole.

Ole has more than 20 years of experience as a consultant within medical devices and combination products. In addition, 8 years of experience as line and project manager in international companies, e.g. Nokia, and international experience from several projects, e.g. UK, France, Spain, Finland, China, and USA

Education

Technical University of Denmark
M.Sc. in Engineering (Electrical), 1988.

Experience

Ole has solid experience with:

  • Implementation and optimization of GMP quality management systems.
  • GMP manufacturing.
  • The development function, R&D, incl. design controls and risk management.
  • Process optimization and lean in GMP environments.
  • Writing Notified Body Opinion applications and writing the device part of US NDA applications

MDR/GSPR, 21CFR820 QMSR, 21CFR4, ISO 13485, ISO 14971, IEC 62366-x, ISO 11608-x, ISO 11040-x, etc.

Ole Overgaard