About

The Vision

Capabilities

ConTIPI Medical is spearheaded by a strong management team with extensive experience and proven ability to bring a product from concept to market, and is backed by well-known consultants, in Israel and abroad.

As a dedicated Research and Development (R&D) company, the entire development of its products is conducted within the company

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Urogynecology Background

Concepts behind Intellectual Property (IP) were conceived by an experienced urogynecologist
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Internal Idea Conception

Early stages of brainstorming & idea conception done internally, further backed by well-known external consultants.
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Extensive Intellectual Property

Extensive IP developed internally together with the company’s patent attorneys. Many patents applications cover various aspects of the Intellectual Property
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Creative R&D Team

Mechanical R&D is managed in-house with further involvement of external consultants, in Israel and abroad.
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In-house Production Abilities

Sample products and final products assembly are done within ConTIPI Medical’s clean room (on the premises)
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Regulatory Affairs

Regulatory affairs are managed in-house, backed by well-known consultants in the US and in Europe
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Clinical Studies

Clinical studies of all stages alone or with a CRO, in Israel and abroad, are conducted by the company itself
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Business Experts

Business aspects and strategies are backed by well-recognized business experts

The Management

Dr. Elan Ziv
CEO & Medical Director
MD, OBGYN, FPMRS
Meital Vaknin-Shimony
VP Operations
B.Sc., MBA,
Zohar Tyroler
VP Research & Development
B.Sc., MBA

Advisory Board

Dr. Elan Ziv
MD OBGYN FPMRS, Israel
Dr. Harvey A Winkler
MD OBGYN FPMRS USA

Regulatory Affairs and Clinical Research at ConTIPI Medical

Within an R&D company, regulatory affairs and clinical research play an important role in both development of the products and in post-development clinical assessment.

ConTIPI Medical has extensive in-house capabilities both in regulatory affairs and in clinical studies, conducting its clinical trials either by itself or with a CRO, in Israel or abroad.

Regulatory affairs and clinical research at ConTIPI is headed by Tsvia Erlich and is backed by Hogan Lovells in Washington DC, USA

Quality Assurance

ConTIPI Medical Ltd. is certified for ISO 13485 since 2006.
The quality system complies with FDA QSR (21CFR Part 820)
The company is CE certified according to the medical device Directive 93/42/EEC by MDC CE0483, Germany.
The company is committed to continuous innovations and improvements of its production facilities, product quality, meeting customer needs and applicable regulatory requirements.
The development process is done according to Design Control procedures of ISO 13485 and FDA QSR (21CFR Part 820).

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