Ira Hadas, B.Sc

Medical Device Sales & Marketing Manager

Ira gained her knowledge and experience in Quality and Regulatory Affairs for Medical Devices and OTC Drugs as QA/RA Manager, being responsible for maintaining a quality division in compliance to regulatory requirements such as GMP CFR 21 Parts 210/211/820, EN ISO 13485:2012, CMDCAS ISO 13485:2003, MoH- AMAR.

Before Joining Gsap Ira worked in MIS and Sion Medical.

With over 10 years of experience in Medical Device and OTC Companies, she has an extensive practice in implementing Risk Management for production and development, writing technical files and design history files as well as SOP’s, preparing AMAR, CE, Health Canada and 510(k) submissions, performing internal; vendor and external audits, preparing and performing sterilization validations, package integrity & shelf life validations and cleaning validations. Ira a vast experience with production processes in clean room environment.

Ira Holds Bachelor’s degree (BSc) from Tel – Hai College in Biotechnology, with specialization in Microbiology. Ira holds a Lead Auditor certificate from SII.

During her work in Gsap Ira lead Projects in the following companies: Philips, Biosence Webster, Melcap Systems, Nurami Medical, Global E and Upstep.

Creativity is a natural extension of our enthusiasm
Earl Nightingale