ISO 13485

Every major jurisdiction requires a quality system as part of their
market access approval process and outlines specific requirements the
quality system must incorporate. Every manufacturer, regardless of
their product's risk classification, must implement a compliant
quality system.

A quality management system provides a structured and disciplined
series of key processes to ensure a company consistently complies with
requirements during its day to day operations. Put simply, in the
highly regulated medical field each and every product you manufacture
is virtually identical to the one that you submitted for market access
approval. No variation is allowed!

One quality management system, fully integrating all requirements with
one implementation and one registration process providing worldwide
regulatory acceptance. Horizon Phoenix experts do that every day.
The only variable is what markets you want to access. Horizon Phoenix
experts match your marketing efforts with your regulatory objectives
to ensure you get what you need quickly and cost effectively.

USFDA QSR, no problem. CAN/CSA/ISO 13485 or maybe EN/ISO 13485, can do! How about Japanese MHLW Ordinance 169 or just cGMPs or cGLPs, yes we can. Want to use corporate guidelines but need regulatory
approvals, we can help you with that too!

Horizon Phoenix experts understand there are many quality objectives
you need to meet besides ISO quality system registration. We work
with the end in mind and that end is what you want and what you need
to achieve your goals and frequently that goes beyond worldwide market
access!

The process is simple - we look at what you do and compare that to
what you need based on your marketing direction and company
objectives. No wholesale changes, no complete rewrite of policy or
procedures, no cookie cutter mentality. Each and every activity is
customized to your needs, goals and marketplace.

One quality management system equals worldwide acceptance.

Ask us how...