Product development

The right know-how and full competences

Your full service CRO for medical product development

1MED is renowned for its specialty in medical device design, development and validation,whilst retaining in-house experience and contacts to support pharmaceutical product development. Our familiarity with regulatory variations and industry trends maintains our approach to device development current and forward-looking.

The scientific principles upon which a device is based are fundamental to its safety and performance. The more complex the device, the higher risk of user error. Soundness of concept and adequacy of design, manufacture, and testing, including verification, validation and clinical trials, require the scrutiny of scientific experts to ensure that design parameters and performance characteristics do not impose unwarranted risks on the end user.

1MED HAS A FULL RANGE OF COMPETENCES IN THE MEDTECH INDUSTRY

Services and support for:

  • Investor’s due diligence assessment 
  • Medical device feasibility analysis 
  • Gap analysis & regulatory strategy plan
  • Design of preclinical studies (ex-vivo & in vivo)
  • Device design and development plan
  • Selection and management of industrial partners
  • Identification of laboratories for test and validations

PRE-CLINICAL STUDIES

1MED is your proactive collaborative CRO partner and looks to save you time and resources through the pre-clinical and clinical phases. Our strategic partnership with 1LAB provides you with reliable and viable clinical evidence on the feasibility of your ideas. 1LAB, branch company of 1MED, is a specialized laboratory in advanced pre-clinical in vitro testing which uses biomaterial scaffolding and tissue engineering technology to replicate human vessels, skin, and mucosa. 1LAB’s multidisciplinary approach is scientifically backed and is equipped with highly trained staff and with robust industry experience.  Our 1LAB partnership gives us a powerful tool in generating reliable and replicable high-quality data in preparation for clinical trials.