Miri Rotenstein's Contact Details

Miri Rotenstein's Company Details

HaMaDa Regulatory, Clinical & Quality Affairs

, , • 15 Employees
Medical Devices

HaMaDa is a Regulatory and Clinical Affairs and Quality Assurance Consulting Office for the Medical Device Industry. We are dedicated to guiding medical device and life science companies through the product life cycle, development phases to successful launch and sustain products in the international marketplace. We guide entrepreneurs, companies and investors through the regulatory, clinical and Quality Assurance (QA) maze. HaMaDa has the vital experience necessary to expedite the regulatory approval process and provides a wide range of services, for start-ups as well as established companies. For early stage companies, we can help define the best strategic and tactical steps to pave the way into the market. For well-established companies, our experience can complement in-house expertise to assist with specific quality and regulatory activities such as writing Clinical Evaluations etc., as well as provide training for personnel or execute internal audits of your QSR and/or ISO 13485 quality system.Our highly qualified team of professionals keeps completely updated on current global regulations and standards so that our clients can focus on their core business while being confident that they are getting the necessary regulatory assistance and support.