ProductEx_0.png
Product Expertise
Understanding the science behind your product
Orphan drugs, biologics, or implantable devices present completely different challenges.
Our work is led by product specialists, experienced in bringing to the market the type of
product that our clients are developing.
An “in vitro diagnostic medical device” (IVD) is a medical device, reagent, instrument or software, which is intended to be used in vitro for the examination of specimens derived from the human body, for diagnostic purposes. These diagnostic tests may provide information concerning a pathological disease or a predisposition to a medical condition or disease, but may also predict treatment response or reactions. Read More

VCLS Solutions

Science-based, global product development strategy and planning

  • Position product and claims
  • Assist in innovative product classification and development plans
  • Develop roadmaps towards international market approvals (EU, US, Australasia, South America)
  • Advise on/conduct regulatory bodies strategic, and product development meetings (Notified Bodies, EU Competent Authorities, FDA) Tactical operations
  • Assist with risks analysis and risk management plan
  • Develop and submit regulatory files (EU CE mark Technical File, US 510k & PMA, Canada, Australasia, South America)
  • Optimize quality and vigilance systems
  • Advise on labeling and advertising
Tactical operations

  • Assist with risks analysis and risk management plan
  • Develop and submit regulatory files (EU CE mark Technical File, US 510k & PMA, Canada, Australasia, South America)
  • Optimize quality and vigilance systems
  • Advise on labeling and advertising