The BioMedical Strategy Group

Your Global Medical Device Compliance Partner

BioMedical Strategy, led by Dr. Orna Oz, is a unique and highly qualified consulting group providing pre-clinical, clinical and regulatory strategic planning. We are committed to delivering healthcare product companies with the utmost efficient and cost-effective approach for product entry to the world markets, including the U.S., Europe, Israel and elsewhere.

ABOUT US

"Biomedical Strategy is considered one of the top regulatory consultants in Israel, of all the consultants we examined, their group were a head above the rest."

Ophir Lotan, VP Product, Tyto Care (2019)

BioMedical Strategy's Services

"Highly dedicated, professional team that do not only provide advise but perform end-to-end writing and support the company throughout the entire process, from the strategy to the execution phase of development."

Nir Israeli, CEO, Sanoculis (2019)

“They will tell you what you need to hear instead of what you want to hear, leading to a fast and more cost-effective process.”

Omer Zelka, Founder & CEO, ElastiMed (2019)

"In depth understanding of both the products and regulatory process lead us to choose the right path to a fast, cost-effective regulatory approval.

Gera Stommer, Chairman &CEO, Newpace (2019)

Strategic Planning

Regulatory Compliance

"Very satisfied because we achieved FDA approval in a relatively short time line as we had hoped."

Avner Halperin, CEO, EarlySense (2019)

“Orna & her group take the time to become part of your company’ DNA. Their in-depth knowledge about our product and its competitive landscape were crucial for the process to succeed. Their clinical evaluation report was excellent, and we received the CE approval."

Livnat Ben-Zur, General Manager & VP Business Development, Regentis Biomaterials (2019)

Pre/Non-Clinical & Clinical Activities

Post Market Surveillance

"Orna and her team are our first-in-line for any FDA submission activity, as well as professional services for clinical regulatory documentation."

Yehudit Kraizer, Director Regulatory Affairs, Lumenis Israel (2019)

"Orna & her team are the most suitable consulting group for a startup because of their ability to simultaneously lead the process with extraordinary expertise while having the flexibility to adapt to the ever-changing needs of a startup."

Avner Halperin, CEO, Earlysense (2019)