A "one health" approach applied to devices

Specific expertise in medical devices field

OHC was founded by Sandra who built her field experience of more than 15 years in the hospital as well as in the industry at Allergan, bioMérieux and other medical device companies in the sectors of orthopaedics, dental & maxillofacial, cardiology, and abdominopelvic surgery.

Sandra Dejean

The founder

Sandra Dejean, Doctor of Pharmacy, Laureate of the National Academy of Pharmacy and specialized in medical devices and veterinary devices, founded OHC in 2017.

Discover her background

Sandra has been able to achieve regulatory compliance in multiple environments.

  • Various organizational contexts

    Within R&D teams, from start-ups to mature international companies as well as with very tight deadlines or with financial and small-team constraints.

  • Various products

    Prostheses, osteosynthesis, dermal fillers, haemostatic agents, bone substitutes, implantable devices, braces, in vitro reagents, materials of animal origin, devices incorporating drugs and blood derivatives.

  • Various marketing objectives

    CE marking, FDA and Health Canada clearance and licence or compliance activities via subsidiaries and distributors for Europe Middle East Africa, Latin America and Asia Pacific areas.

This expertise makes OHC able to find feasible solutions adapted to the typology of each company.

Unique expertise in devices for veterinary use

Thanks to innovative work and initiatives carried out over more than 7 years, Sandra has been able to interact with:

  • organizations representing companies in in vitro diagnostics and medical devices for animal health,

  • associations and organizations at European and international level,

  • veterinarians,

  • a competitiveness cluster for the equine sector,

  • animal health regulatory authorities.

This interest and this unique approach allow OHC to be at the moment the only consulting company to strive for a One Health approach in the medical device field. OHC supports manufacturers of veterinary devices and diagnostics in integrating relevant regulatory requirements while developing best practices for design and manufacturing to ensure: clinical benefit and safety for the animals, demonstration of quality for users, an approach of environmental sustainability and synergies with human health.

A strategy consulting firm rooted in the healthcare landscape

Based in Lyon/Villeurbanne at the heart of a regional ecosystem recognized in human health and which hosts the first global hub in veterinary public health, OHC relies on its internal skills and on original partnerships to identify and implement operational and functional solutions for regulatory compliance in human and animal health.

Why OHC…at a glance

  • Customization

    Build non-standardized solutions adapted to your organization and enhancing your device in the clinical and competitive strategy.

  • Orientation

    Be product-, patient-, and user- oriented for a regulatory compliance process demonstrating the benefit of your device in the therapeutic strategy.

  • Facilitation

    Use an acquired multi-contextual experience to identify regulatory compliance options that minimize the constraints and are viable in the long term.

  • Innovation

    Identify the connections between human and animal health to innovate and maintain your device on the market.
 

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