How do we do this

We guide you to your clinical grade product

Medace offers a full service work-learning environment where you (whether you are an academic or an entrepreneur) are guided in how to set up and develop the technical dossier needed for clinical validation whilst producing your clinical grade product. The Medace concept is certified according to the latest Medical Device regulations (EN ISO 13485:2016) and has succesfully been used by our clients to obtain their GMP Manufacturing License.

Medace provides:

  • Specialized infrastructure (e.g. ISO7 and 8, and Class C and B cleanrooms)
  • Office working space
  • Validated and specialized equipment
  • Quality Management System
  • Trained professionals for hands-on guidance and support during development and validation
  • Dedicated in-house training programs

You will:

  • Significantly reduce investment in rent and personnel
  • Learn from experts and other users – first time right
  • Increase your chances for higher ROI by faster development of your products
  • Internalize critical expertise over time and keep control over primary processes and production

By sharing expertise, infrastructure and equipment, we improve product quality, increase efficiency and reduce costs.

Medace accelerates the road from Patent to Patient.