Our approach is based on a specific knowledge of the medical devices field acquired since 2007:
– on multiple products (prostheses, osteosynthesis, dermal fillers, hemostatic agents, bone substitutes, implants, braces, in vitro reagents, materials of animal origin); and
– in multiple clinical areas (dental & maxillo facial, orthopaedics, cardiac, abdomio-pelvic surgery, veterinary, aesthetic medicine).
Coaching performed by OHC enables to optimize the implementation of international development strategies thanks to our previous experience in obtaining and maintaining regulatory approvals:
– to market devices in various regions: Europe Middle East Africa, Latin America, Asia-Pacific and North America
– in various contexts: direct communications with regulatory bodies (notified bodies (CE marking), FDA, Health Canada) or through subsidiaries and distributors.
We provide us with a 360°- support thanks to the regulatory experience acquired in different environments (various structures and sizes of companies, shortened marketing times, human and financial resource constraints) :
– at each phase of your project (concept, development, management of changes and improvements of the product);
– at different levels (clinical, technical, scientific and organizational positioning).
A strategy built around your needs.
We help you integrate regulatory requirements strategically to improve product development processes and the time-to-market.
We support you in translating regulatory requirements into the language of your business. We also help you prioritizing and planning their integration.
We help you identify, anticipate and control business and product risks related to deviations from regulatory requirements.
Sandra DEJEAN, PharmD
Doctor of Pharmacy with a master’s degree in health engineering option medical devices and ancillaty medicinal substances, I have worked in the medical devices sector for many years. I have observed that regulatory and quality activities were often suffered while they are a great springboard for positioning in the healthcare market and for creating a competitive and technological advantage.
Based on these observations, I want to provide a coaching and support approach for healthcare companies that relies on this strategic aspect.
I also relies on the “one health” concept to set up a dynamic, collaborative and complementary approach for human and veterinary health products.