Device Certification

Medical devices cover a wide range of products starting from a syringe or a clinical thermometer up to new devices coated with new active substances used to treat severe medical conditions like e.g. myocardial infarction or specific software intended to diagnose specific diseases. The same holds true for in-vitro diagnostics which could be intended to measure simple blood parameters like e.g. glucose or, fuelled by gene technology, they are now becoming very specific tools for the analysis of medical conditions or gene abnormalities. Depending of the complexity of your product data generated according to an individual tailor-made development plan will be needed to show that your product meets all the requirements and can be marketed.

We support you in:

• Defining an individual development strategy based on your products characteristics
• Interacting with the respective responsible regulatory bodies to confirm acceptability of the development plan
• Assisting you throughout the certification process

• Regulatory Strategy
• Regulatory Procedures
• Advanced Therapies
• Orphan Drug Development
• Paediatric Development
• Medical Devices
  • Device Certification
  • Europe
  • United States
• Borderline Products
• Authority Meetings
• Electronic Submissions
• Market Access & Value Dossier
• Small & Medium Enterprises
• Medical Writing
• Project Management
• Due Diligence

• Business Development