MEDICAL TECHNOLOGY

Technology know-how and knowledge of laws, standards and regulations.

Micropool mainly implements projects in laboratory automation, analytics and diagnostics (in vitro diagnostic). Our emphasis in the medical technology lies in the development of sensors, measuring and diagnostic instruments.

Micropool is certified according to the newest standard ISO 13485 and is familiar with the special requirements applicable in medical technology:

– Guarantee of product security

– Fulfillment of the legal demands, standards and regulations

– Requirement management

  • Risk management according to ISO 14971
  • Risk analysis / FMEA
  • Traceability in production
  • Process- and product-verification / -validating
  • Product- and process-documentation
  • Filing of all relevant documents