Our product portfolio spans multiple regulatory boundaries with device classifications ranging from Class I non-sterile through Class II and up to Class III.
Our team of Quality and Regulatory professionals is dedicated to ensuring that the organisation is fully compliant with the varied regulatory requirements needed to support the product portfolio, customer base, and multiple routes to market.
FW has a long standing ISO 13485 and 21 CFR part 820 compliant Quality Management System which provides the framework for consistent and controlled design and manufacture practices. In addition, we have the CE Marking capability via Annex II or Annex V to place products directly onto the EU market, or in collaboration with customers via the Own Brand Labelling Route. First Water is a registered Contract Manufacturer with the FDA, enabling our customers to market and distribute products we make for them with the USA.
To attain the highest levels of quality, we are working continually to develop our processes and to sew a philosophical approach to quality into the very fabric of the organisation.